Reported trial results for Irritable Bowel Syndrome
Every Irritable Bowel Syndrome trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
26 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT05744258 · results posted 29 May 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 20 people who had been diagnosed with Irritable Bowel Syndrome (IBS) and 20 healthy volunteers without IBS. Of the IBS group, 16 people completed the study (4 did not finish), while all 20 healthy volunteers completed it. The trial was not testing a treatment; instead, it was measuring differences in body composition — things like body water, muscle, and fat levels — between the two groups. These measurements were taken using a technique called Bio-electrical Impedance Analysis (BIA), which sends a small electrical signal through the body to estimate its make-up. The reported data shows the following average figures for each group. For a measurement called "phase angle" (a general indicator of how cells in the body hold fluid — a higher number is sometimes considered more typical), the IBS group recorded 5.78 degrees compared to 6.35 degrees in the healthy group. For total body water as a percentage, the IBS group recorded 63.4% versus 72.3% in the healthy group. For muscle mass as a percentage, the IBS group recorded 42.9% compared to 52.6% in the healthy group. For body fat as a percentage, the IBS group recorded 46.8% compared to 53.7% in the healthy group. No further details — such as the range of individual results or whether these differences were considered statistically meaningful — were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03983434 · results posted 30 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03983434) enrolled 29 people in total across three groups: 17 healthy volunteers, 3 people with irritable bowel syndrome (IBS) with constipation, and 9 people with IBS with diarrhoea. The trial measured certain chemicals found in stool — specifically bile acids (substances involved in digestion) and short-chain fatty acids (substances produced by gut bacteria when they break down food) — as well as the variety of bacteria living in the gut. Stool samples were collected over 48 hours and analysed in a laboratory. Not everyone finished the study: 16 healthy volunteers, 2 IBS-constipation participants, and 6 IBS-diarrhoea participants completed it. The reported data shows the following measurements from stool samples. For total bile acids (measured over 48 hours), healthy volunteers recorded 471.5 units, IBS-constipation participants recorded 347 units, and IBS-diarrhoea participants recorded 329.5 units. For total short-chain fatty acids, healthy volunteers recorded 359.8 units, IBS-constipation participants recorded 157.1 units, and IBS-diarrhoea participants recorded 276.9 units. When broken down into individual fatty acids, healthy volunteers consistently recorded higher figures across acetate, propionate, and butyrate compared to both IBS groups. For gut bacteria diversity (measured using a score called the Shannon index, where a higher number means more variety of species), healthy volunteers scored 3.0 and IBS-diarrhoea participants scored 3.6. The reported data shows no Shannon index figure was provided for the IBS-constipation group. It is worth noting that the IBS-constipation group was very small (only 2–3 people), so these numbers represent a very limited snapshot. The trial was measuring and comparing these gut chemistry markers across the three groups, not testing a treatment or intervention. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02291445 · results posted 24 January 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 people in total — 4 in each group — and all 8 completed the study. It was a crossover trial, meaning each participant tried both forms of peppermint oil capsule at different times: one that releases in the small intestine, and one that releases further along in the gut (in the ileocolonic region, which is where the small and large intestines meet). The trial was measuring how a substance called menthol-glucuronide — the main form peppermint oil takes after being processed by the liver — behaved in the bloodstream after each type of capsule was taken. The reported data shows that the primary measurement was how long it took for menthol-glucuronide to reach its highest level in the blood. For the ileocolonic-release capsule, that peak was reached at 360 minutes (6 hours) after taking it, compared to 180 minutes (3 hours) for the small-intestinal-release capsule. The reported data also shows that the first detectable level of menthol-glucuronide in the blood appeared much earlier with the small-intestinal-release capsule (at 37 minutes) compared to the ileocolonic-release capsule (at 225 minutes). The highest recorded blood concentration was 702 micrograms per litre for the small-intestinal-release capsule and 563.6 micrograms per litre for the ileocolonic-release capsule. The overall exposure to menthol-glucuronide over 24 hours (a measure of the total amount that entered the bloodstream) was broadly similar between the two: 2,623 and 2,331 (in standard measurement units) respectively. The time for blood concentrations to fall by half was reported as 7.7 hours for the small-intestinal-release capsule and 6.1 hours for the ileocolonic-release capsule. Results for urine excretion were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01199302 · results posted 28 December 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 67 people in total across four groups. Each group received a different dosing arrangement of brodalumab (an investigational medicine) or a placebo, with most participants later switching to a standard dose of brodalumab. The trial was measuring undesirable medical events that occurred during treatment, changes in disease activity scores for Crohn's disease (a condition causing ongoing gut inflammation), and whether participants' scores crossed thresholds defined as a meaningful response or remission. The reported data shows that when it came to undesirable medical events during the study, between 8 and 18 participants in each group experienced at least one such event, and between 2 and 5 in each group experienced a serious event (meaning one that was severe enough to require hospitalisation or met similar serious criteria). No deaths were reported. For the disease activity score — called the CDAI, where lower numbers mean less active disease — the reported data shows that the percentage of participants whose score dropped by 100 points or more (considered a meaningful response) ranged from around 21% to 55% depending on the group and the time point measured. The percentage reaching what was defined as remission (a score of 150 or below) ranged from 0% to about 33% across groups and time points. The reported data also shows that no participant in any group developed antibodies (immune proteins) against the study medicine. It is worth noting that the structured results list zero completions across all groups, which may reflect how the study's phases were recorded rather than meaning no one finished. These figures describe what was measured and counted — they do not on their own tell us whether any difference between groups was meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03806127 · results posted 30 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03806127) enrolled 222 adults with a type of irritable bowel syndrome characterised by diarrhoea (IBS-D), with 111 people assigned to receive a daily 75 mg dose of a medicine called vibegron and 111 people assigned to receive a placebo (a dummy pill with no active ingredient). By the end of the 12-week study, 99 people in the vibegron group and 90 in the placebo group had completed the trial. The main thing the trial was measuring was how many participants in each group experienced a meaningful reduction in their worst abdominal (tummy) pain over the 12 weeks — specifically, whether their pain dropped by at least 30% from their starting level for at least half of the weeks assessed. The reported data shows that, for the primary measure, 27 out of 111 participants in the vibegron group and 27 out of 111 in the placebo group met this pain-reduction threshold. For a secondary measure looking at a stricter 40% pain reduction, 22 vibegron participants and 20 placebo participants qualified; at an even stricter 50% reduction, 18 vibegron and 13 placebo participants qualified. When participants were asked to rate their overall IBS symptoms (the Global Improvement Scale), the reported data shows that across all IBS participants combined, 44 in the vibegron group and 37 in the placebo group said their symptoms were "moderately" or "significantly" relieved. Regarding side effects (called treatment-emergent adverse events), 37 participants in each group reported at least one event that began or worsened after starting their assigned treatment. The reported data also shows that no participants in either group had clinically meaningful changes in laboratory test values at week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01412372 · results posted 31 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 30 in the placebo group and 31 in the mesalamine group. Of those, 26 and 28 participants respectively finished the full study. The trial ran for eight weeks and was measuring whether mesalamine (a medication sometimes used for gut inflammation) had any impact on bowel symptoms, quality of life, and related measures in people with irritable bowel syndrome (IBS), compared to a placebo (a dummy treatment with no active ingredient). The reported data shows that the main thing being measured was a "Bowel Symptom Score" — a combined rating of pain, bloating, diarrhoea, constipation, and satisfaction with bowel habits, scored from 0 (not severe) to 100 (very severe). After eight weeks, the placebo group's score dropped by 4 points on average, while the mesalamine group's score dropped by 13 points on average. For the secondary measures: a quality-of-life questionnaire (scored 0–100) showed an average improvement of 4 points in the placebo group and 8 points in the mesalamine group. Daily bowel movement frequency changed by 0.0 in the placebo group and decreased by 0.9 in the mesalamine group. Stool consistency (rated 1–7) changed by −0.5 in the placebo group and −0.8 in the mesalamine group. The abdominal pain score dropped by 5 points in the placebo group and 9 points in the mesalamine group. The bloating score dropped by 4 points in the placebo group and 8 points in the mesalamine group. It is worth noting that the reported data does not include information about how statistically meaningful these differences between groups were, so those figures cannot be interpreted further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03241368 · results posted 9 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people who already had a known diagnosis of Crohn's disease. The trial was comparing three different ways of looking at the bowel for signs of active Crohn's disease: capsule endoscopy (CE, where a person swallows a tiny camera in a pill), ileocolonoscopy (IC, a standard camera procedure), and MR enterography (MRE, a type of MRI scan that looks at the bowel). Of the 158 people who started, 119 completed the trial and 39 did not complete it. The reported data shows that the primary thing being measured was how accurately the swallowed camera (CE) could detect active Crohn's disease across the small bowel and colon compared to the combination of ileocolonoscopy and MRI. The four percentage figures reported for this primary measure were 94%, 100%, 74%, and 22%, though the data as submitted does not clearly label which specific measurement each figure corresponds to, so they cannot be described individually with certainty. For the secondary outcomes, the reported data shows figures related to how reliably CE could rule in or rule out active disease in different sections of the bowel — with percentages ranging from 37% to 98% across various measures in the proximal small bowel, terminal ileum, and colon segments. Regarding patient satisfaction, the reported data shows that 64 participants preferred the capsule endoscopy procedure, 43 preferred the ileocolonoscopy, and 11 preferred the MRI combined with ileocolonoscopy. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02559206 · results posted 24 April 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 532 adults across eight groups to compare different formulations and doses of a drug called linaclotide against a placebo (a dummy treatment) in people with a condition involving abdominal pain and constipation. The drug was tested in its standard form (IR, meaning immediate-release) as well as two newer delayed-release versions (DR1 and DR2) at three different doses each — 30, 100, and 300 micrograms. The trial ran for 12 weeks and measured two main things: how much abdominal pain changed over time (rated on a 0–10 scale), and how often participants had what the researchers called a "complete spontaneous bowel movement" (a bowel movement that felt fully relieving and happened without the use of laxatives). The reported data shows that all groups — including the placebo group — recorded a reduction in their abdominal pain scores from their starting point over the 12 weeks. The placebo group's average pain score dropped by 1.37 points. The standard linaclotide (IR) group dropped by 1.94 points. Among the DR1 formulation groups, the drops were 1.67, 1.66, and 2.14 points for the 30, 100, and 300 microgram doses respectively. For the DR2 formulation, the reported drops were 1.83, 1.67, and 1.63 points. For bowel movements, the placebo group gained about 1.1 additional complete bowel movements per week on average. The IR group gained about 2.1 per week. The DR1 groups gained 1.16, 1.41, and 1.78 per week, while the DR2 groups gained 1.28, 1.02, and 0.87 per week. For the combined responder measure — people who met both the pain and bowel movement improvement targets for at least 6 of the 12 weeks — the reported data shows 14 out of 52–66 participants in the placebo group met this threshold, compared to 21 out of 45 in the IR group, 18, 17, and 26 in the DR1 groups, and 16, 16, and 14 in the DR2 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02544152 · results posted 27 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people in total — 34 in the placebo group and 37 in the lubiprostone group. The trial was measuring how well participants with abdominal pain responded to treatment over a number of weeks, using a scale where participants rated their worst pain in the past 24 hours from 0 (no pain) to 10 (worst possible pain). The main thing the trial was looking at was how many people in each group could be classed as an "overall responder" for abdominal pain — meaning their pain had dropped by at least 30% compared to their starting level for at least 75% of the weeks they were in the trial. By the end of the study, 33 people in the placebo group and 30 in the lubiprostone group had completed the trial. The reported data shows that for the main outcome — overall abdominal pain response — 10 out of 34 people in the placebo group and 11 out of 37 people in the lubiprostone group met the responder criteria. For the secondary outcomes, the numbers of weekly and monthly pain responders were broadly similar between the two groups at most time points measured. When it came to stool consistency, the reported data shows that over the course of the study, no participants in the placebo group were classed as an overall responder for stool consistency, compared to 3 out of 37 in the lubiprostone group. In the earlier months, more participants in the lubiprostone group met the weekly and monthly stool consistency response criteria, though the numbers became more similar between groups by the later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03154086 · results posted 9 August 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03154086) tested an investigational medicine called GSK3352589. It was run in two main parts. Part A was an early-stage, dose-finding section where healthy volunteers received single doses of GSK3352589 (ranging from 2 mg up to 400 mg) or a placebo (a dummy treatment with no active ingredient), with some sessions testing the drug on an empty stomach versus after a meal. Part B then looked at participants receiving twice-daily doses (ranging from 5 mg to 200 mg) or placebo over a longer period. Across all the groups and dosing periods, the total number of participants who started the trial ranged from small groups of 2 people in some early cohorts up to larger groups in Part B, with roughly 6–10 people per active-dose group in Part B. The trial was primarily measuring how the body absorbs, processes, and clears the drug — often called pharmacokinetics — as well as monitoring safety-related measurements. The reported data shows that the primary outcome measures focused on how much of the drug entered the bloodstream and how long it stayed there, captured by figures such as the highest drug level reached in the blood and the total amount of drug exposure over time. The reported data shows these numbers varied across the different dose levels, generally rising as the dose increased, though the specific numerical values for many of the pharmacokinetic measurements were not fully reported in the structured data available. For the food-effect part of the trial, measurements were taken comparing fasted and fed conditions for the 25 mg dose. Secondary outcome measures included additional blood-level tracking points, but again, full numerical results for several of these were not reported in the structured data submitted. It is worth noting that this was an early-phase trial conducted in a small number of participants, and its primary purpose was to gather initial information about how the drug behaves in the body — not to draw broad conclusions about the medicine's role in treating any condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00765999 · results posted 15 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00765999) enrolled 1,554 participants, all of whom received the study drug linaclotide. This was a single-group, open-label study, meaning everyone received the same treatment with no comparison group. Of those who started, 770 completed the study and 784 did not complete it. The trial was measuring what happened to participants while they were taking linaclotide, with a focus on tracking any unwanted or unexpected medical events (called "treatment-emergent adverse events," or TEAEs) that occurred after starting the medication. The reported data shows that the primary outcome measured was the number of participants who experienced at least one such unwanted medical event during the treatment period. Results were broken down into two sub-groups based on the participants' conditions. In the group described as "Linaclotide (CC)" — likely referring to one condition — 399 participants were reported to have experienced at least one such event. In the group described as "Linaclotide (IBS-C)" — likely referring to another condition — 748 participants were reported to have experienced at least one such event. No secondary outcome measure data was included in the submitted results. It is worth noting that the total number of participants across these two sub-groups (1,147) appears higher than the number who completed the study, which may reflect how the groups were defined; however, the data does not provide further explanation of this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02641392 · results posted 29 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02641392) involved three groups of participants who received different doses or schedules of a drug called GED-0301: 4 people received a 40 mg alternating schedule, 13 received a standard 40 mg dose, and 293 received a 160 mg alternating schedule — giving a total of 310 participants. The trial ran for up to 208 weeks (roughly four years). Notably, the reported data shows that none of the participants in any group were recorded as having completed the study — all participants were listed under "not completed." The primary outcome the trial measured was the number of participants who experienced treatment-emergent adverse events (that is, any unwanted health event that happened during or shortly after treatment). The reported data shows that in the 160 mg alternating schedule group — the largest group with 293 participants — 189 people experienced some form of adverse event during the study period. Of those, 43 experienced a serious adverse event (meaning one that led to hospitalisation, was life-threatening, or had another significant medical consequence), 38 experienced a severe adverse event (meaning symptoms causing severe discomfort or pain), and 41 experienced an event in a fourth category, though the label for that category was not clearly specified in the data. In the smaller groups, the numbers were much lower, which is consistent with those groups having far fewer participants. No additional outcome measures beyond this adverse event count were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT02757105 · results posted 31 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 75 people in the RHB-102 group and 52 people in the placebo (dummy pill) group — 127 participants in total. The trial was measuring what is called a "stool consistency response" in people with diarrhoea-predominant irritable bowel syndrome (IBS-D). To count as a "responder," a participant needed to have at least 50% fewer days per week with loose or watery stools (rated Type 6 or 7 on a standard stool chart), without any notable increase in their abdominal pain, and they needed to meet this target in at least half of the treatment weeks. The reported data shows that, in the main analysis group, 42 out of 75 participants (around 56%) in the RHB-102 group met the response criteria, compared with 18 out of 33 participants (around 55%) in the placebo group. When the results were broken down by sex, the reported data shows 11 of 11 males in the RHB-102 group met the criteria versus 5 of 11 in the placebo group, and 31 of 22 females in the RHB-102 group versus 13 of 22 in the placebo group — though the numbers as reported are somewhat difficult to interpret and may reflect how the analysis groups were structured. A separate analysis that did not adjust for use of rescue medication reported similar figures: 43 responders in the RHB-102 group versus 19 in the placebo group. The trial also looked at participants split by a blood marker (CRP, a general measure of inflammation): among those with higher baseline CRP, 22 of 15 in the RHB-102 group versus 6 of 20 in the placebo group were reported as responders; among those with lower baseline CRP, 20 of 18 versus 12 of 13 respectively. Where the reported responder count appears larger than the group size, this likely reflects a difference in how the analysis population was counted, and the data was not reported in a way that fully clarifies this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02388269 · results posted 6 February 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02388269) looked at a device called gammaCore®-G in people with functional gastrointestinal disorders — specifically functional dyspepsia (a condition causing ongoing stomach discomfort or pain without a clear physical cause) and irritable bowel syndrome (IBS). A total of 91 people were enrolled: 41 were randomly assigned to the active device, 40 to a sham (dummy) version of the device, and 10 were in a non-randomised group. Of those randomly assigned, 32 in the active group and 38 in the sham group completed the study. The trial's main focus was measuring changes in symptom scores on two questionnaires — one for dyspepsia symptoms (the GOS scale, scored 10–70) and one for IBS symptoms (the IBS severity score, scored 0–500). The reported data shows that on the GOS dyspepsia scale, the active device group's score changed by −0.6 points (a small decrease, meaning slightly fewer reported symptoms), while the sham group's score changed by −1.29 points. For the IBS severity score, the active group's score changed by −46.84 points and the sham group's score changed by −40.24 points — both representing reductions from their starting scores, with both groups moving in a similar direction. For a secondary symptom-change measure comparing scores at 8 weeks versus 4 weeks, the reported data shows a GOS change of −0.03 (active) versus −0.13 (sham), and an IBS score change of +0.27 (active) versus −34.90 (sham). The reported data also shows that on a quality-of-life questionnaire (scored 1–5), scores across the active and sham groups were broadly similar throughout the study. Regarding adverse events (unwanted health occurrences recorded during the trial), 31 participants in the total active group and 29 in the total sham group had at least one adverse event reported, with 24 and 20 respectively in each group having what the trial categorised as treatment-emergent adverse events. The data does not allow conclusions to be drawn about whether any differences between groups were meaningful — that detail was not included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00421707 · results posted 26 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 132 participants in total — 67 in one sequence group and 65 in the other. It was a crossover study, meaning participants received different treatments at different times, separated by a washout (rest) period. The trial was testing a medicine called GW876008 (at a dose of 125 mg) against a placebo (a dummy treatment with no active ingredient) in people with Irritable Bowel Syndrome (IBS). The study aimed to measure things like relief from IBS pain and discomfort, overall symptom improvement, and quality of life. The reported data shows that three of the primary goals — measuring whether participants got adequate (satisfactory) relief from IBS symptoms — could not be reported at all. This was because, according to the submission, the relevant question was accidentally never collected through the system used to gather participant responses. For the primary outcomes that were reported, the Global Improvement Scale (a 10-question rating of symptom change) showed that the proportion of participants classified as "responders" (those showing improvement) was reported as between roughly 0.18 and 0.30 across different symptom areas for the GW876008 group, and between roughly 0.16 and 0.28 for the placebo group. Quality of life scores across several areas (such as emotional health, sleep, and diet) were also reported, with figures appearing broadly similar across the GW876008, placebo, and washout groups. For the secondary outcome on pain and discomfort improvement, the reported data shows that 25 participants in the GW876008 group and 20 in the placebo group were counted as responders at one measured time point, with similar patterns at other time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00477165 · results posted 17 April 2017
According to the results reported on ClinicalTrials.gov, this trial looked at whether citalopram (an antidepressant sometimes explored for gut symptoms, spelled "Cialopram" in the participant data but referred to as "Citalopram" in the outcome measures) compared to a placebo (a dummy treatment) could provide relief for people with Irritable Bowel Syndrome (IBS). A total of 54 people took part — 27 in each group. Of those, 20 people in the citalopram group and 25 in the placebo group completed the study, meaning 7 people in the citalopram group and 2 in the placebo group did not finish. The reported data shows that for the main thing being measured — the number of participants who said they felt "adequate relief" from their IBS symptoms in at least 3 out of 6 weeks — 12 out of 27 people in the citalopram group reported this, compared to 15 out of 27 in the placebo group. For quality of life (measured using a questionnaire scored from 0 to 100, where higher means better), both groups showed a small improvement from their starting scores by week 8: the citalopram group's score changed by an average of 6.3 points, and the placebo group's by 7.6 points. The trial also measured physical sensations and urgency to use the bathroom during a controlled procedure involving gentle pressure applied inside the rectum. The reported data shows that sensation and urgency scores across different pressure levels were generally similar or slightly lower in the citalopram group compared to the placebo group, though the exact pressure levels at which each set of scores was recorded were not specified in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02120027 · results posted 18 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02120027) enrolled 277 women in the ibodutant 10 mg group and 279 women in the placebo (dummy tablet) group — 556 participants in total. The trial was measuring whether ibodutant reduced two key symptoms of irritable bowel syndrome with diarrhoea (IBS-D): abdominal pain and loose/watery stools. To count as a "responder," a participant needed to show meaningful improvement in both symptoms during at least half of the 24-week treatment period (that is, at least 12 out of 24 weeks). The reported data shows that for the main (primary) measure — improvement in both abdominal pain and stool consistency together — 51 out of 277 participants in the ibodutant group and 52 out of 279 participants in the placebo group met the response criteria. For the secondary measures, 96 ibodutant participants and 83 placebo participants showed improvement in abdominal pain alone, while 72 ibodutant participants and 71 placebo participants showed improvement in stool consistency alone. When asked about overall relief of their IBS symptoms, 37 ibodutant participants and 29 placebo participants reported being "completely" or "considerably" relieved. A further secondary measure looked at whether responses were sustained right through to the end of the 24 weeks, finding 50 ibodutant participants and 45 placebo participants met that bar. The reported data shows how many people in each group met each measurement threshold; it does not, on its own, establish what caused any differences between the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02107196 · results posted 27 September 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called ibodutant (10 mg) compared to a placebo (a dummy pill with no active ingredient) in women with irritable bowel syndrome with diarrhoea (IBS-D). The trial had two stages: a 12-week treatment period, in which 271 people started on ibodutant and 264 on placebo, followed by a 4-week withdrawal period involving a separate group of 338 and 114 participants respectively. The trial was primarily measuring how many participants had meaningful improvements in both abdominal pain and stool consistency at the same time, across at least half of the 12 treatment weeks. The reported data shows that for the main (primary) outcome — improvement in both abdominal pain and stool consistency together — 35.7% of people taking ibodutant met that definition, compared with 34.7% taking placebo. For the secondary outcomes, which looked at pain and stool consistency separately: 48.0% of the ibodutant group and 47.7% of the placebo group showed improvement in abdominal pain alone; 44.8% versus 43.1% showed improvement in stool consistency alone; and 21.3% versus 19.0% reported feeling their overall IBS symptoms were considerably or completely relieved. The trial also measured whether symptoms "rebounded" after stopping ibodutant, though the data for that part was reported in a way that is not straightforward to summarise in plain numbers from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01880424 · results posted 27 September 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 839 people — 417 in the linaclotide group and 422 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). The trial was measuring symptoms of Irritable Bowel Syndrome with Constipation (IBS-C), specifically looking at abdominal pain and discomfort, overall IBS symptom relief, and bowel movement patterns over 12 weeks. By the end of the study, 384 people in the linaclotide group and 367 in the placebo group had completed the trial. The reported data shows the following numbers for the two main (primary) measures. For abdominal pain and discomfort response — meaning at least a 30% improvement for at least 6 out of 12 weeks — 250 out of 417 participants in the linaclotide group met this threshold, compared with 206 out of 422 in the placebo group. For overall IBS symptom relief — meaning participants reported their symptoms as "considerably" or "completely" relieved for at least 6 out of 12 weeks — 132 out of 417 in the linaclotide group met this threshold, compared with 65 out of 422 in the placebo group. For the secondary measures, the reported data shows that bowel movements without laxatives (including those with a sense of complete emptying) increased more in the linaclotide group than the placebo group over 12 weeks. Stool consistency scores also changed more in the linaclotide group, and straining scores decreased slightly more in the linaclotide group (a decrease of 1.02 points on a 5-point scale) compared to the placebo group (a decrease of 0.69 points). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00724126 · results posted 28 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 637 adults — 321 in the placebo group (a dummy treatment with no active ingredient) and 316 in the rifaximin group. The trial was measuring whether rifaximin, an antibiotic, made a difference to self-reported irritable bowel syndrome (IBS) symptoms. Participants were asked each week whether they felt adequate relief from their overall IBS symptoms, and separately, whether they felt adequate relief from bloating. The main results window covered weeks 3 to 6 of the study, which was the four-week period immediately after two weeks of taking the study medication. Most participants completed the trial — 302 in the placebo group and 301 in the rifaximin group. The reported data shows that, for the main (primary) measure — overall IBS symptom relief for at least 2 out of those 4 weeks — 40.6% of people in the rifaximin group reported adequate relief, compared with 32.2% of people in the placebo group. For the secondary measure — bloating relief for at least 2 out of those 4 weeks — 41.0% of people in the rifaximin group reported adequate relief, compared with 31.9% in the placebo group. In both cases, this means a notable proportion of people in both groups reported feeling relief, including those who received no active treatment at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00731679 · results posted 28 July 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 623 adults — 314 in the placebo group (a dummy treatment with no active ingredient) and 309 in the rifaximin group. The trial was measuring whether people with irritable bowel syndrome (IBS) felt adequate relief from their overall IBS symptoms, and separately from bloating, during the four weeks after finishing two weeks of treatment. Each week, participants were simply asked "yes or no" whether they had felt adequate relief compared to how they felt before the study started. The reported data shows that for overall IBS symptom relief — the main thing being measured — 40.8% of people in the rifaximin group answered "yes" for at least two out of those four weeks, compared with 31.2% in the placebo group. For the secondary measure of bloating relief specifically, 39.5% of the rifaximin group reported adequate relief for at least two of those four weeks, compared with 28.7% in the placebo group. No other outcome figures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01331213 · results posted 3 March 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01331213) enrolled 18 people in total — 8 received pregabalin (a medicine sometimes used for nerve-related conditions) and 10 received a placebo (a dummy treatment with no active ingredient). All 18 participants completed the study with no drop-outs. The trial was measuring how pregabalin compared to placebo on several aspects of how the large bowel (colon) works, including how stiff or flexible the colon is, how it responds to eating a meal, and at what point participants first felt pain when the colon was gently inflated using a small balloon inserted into the bowel. The reported data shows the following numbers across the main measurements. For colon stiffness (how much pressure was needed to reach half the colon's maximum volume), the pregabalin group recorded around 19.0 mmHg before the study procedures and around 16.0 mmHg afterwards, while the placebo group recorded around 16.9 mmHg and 15.8 mmHg respectively. For how the colon responded after a meal (measured as a percentage change in balloon volume), the pregabalin group showed approximately −22.3% and the placebo group approximately −24.5% — a negative number here means the colon's volume decreased after eating, which reflects the colon tightening up in response to food. For the pressure at which participants first reported feeling pain, the pregabalin group averaged 36.0 mmHg and the placebo group averaged 38.0 mmHg. Pain ratings on a 0–100 scale (where 0 = no pain and 100 = extreme pain) were broadly similar between the two groups across four different balloon pressure levels tested. On the secondary measures, fasting colon volume was reported as approximately 120 mL (pregabalin) versus 117 mL (placebo), and a measure of how actively the colon was contracting after a meal was reported as approximately 11.7 (pregabalin) versus 10.2 (placebo), on a mathematical scale used by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01327300 · results posted 12 February 2014
According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning the same participants took both the active treatment (mesalamine) and a placebo at different times, with a three-week "washout" break in between. Seven people were enrolled in total: five started in the group that received mesalamine first, and two started with placebo first. One person dropped out during the washout period, so six people completed the full trial. The trial was measuring changes in gut (gastrointestinal) symptoms, bowel disease severity, quality of life, anxiety and depression scores, signs of inflammation in the bowel lining, and how easily substances pass through the gut wall, all compared between the mesalamine and placebo periods. The reported data shows the following numbers across the outcome measures. For the primary measure — a gut symptom score rated on a 1-to-7 scale (where 7 is the best) — the average change from the starting point was reported as 2.72 units during the mesalamine period and 2.22 units during the placebo period. For a bowel disorder severity index (where lower scores are better), the reported average change was −14.5 points with mesalamine and +17 points with placebo. For quality-of-life scoring (where higher is better, on a 0–100 scale), the reported average change was +11 points with mesalamine and −12.2 points with placebo. For a combined anxiety and depression scale (where lower is better, scored 0–42), the reported change was +1.2 with mesalamine and −2.4 with placebo. For the bowel-lining inflammation measurements (number of participants showing increased inflammatory cells), the reported data shows 2 participants in both groups for one cell type, 3 participants in both groups for a second, and 2 (mesalamine) versus 3 (placebo) for a third. For the gut-wall permeability test (normal being below 0.7), the reported ratios after treatment were 0.07 for mesalamine and 0.04 for placebo. It is worth noting that with only seven participants enrolled, this was a very small trial, and the reported data should be understood in that context. No conclusions about broader populations can be drawn from numbers this small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01303224 · results posted 25 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 565 people in total across four groups. Participants were randomly assigned to take one of three doses of a medicine called ibodutant (1 mg, 3 mg, or 10 mg) or a placebo (a dummy pill with no active ingredient) once daily for 8 weeks. The trial was measuring how many people with irritable bowel syndrome (IBS) reported satisfactory relief of their overall IBS symptoms **and** their abdominal pain or discomfort for at least 6 out of 8 weeks of treatment. The reported data shows that, for the main outcome (satisfactory relief in at least 6 of 8 weeks), the number of participants counted as "responders" out of those in each group was: 45 out of 140 in the 1 mg ibodutant group, 46 out of 138 in the 3 mg group, 55 out of 139 in the 10 mg group, and 39 out of 142 in the placebo group. A secondary measure used a slightly looser rule — satisfactory relief in at least 4 of 8 weeks — and the reported responder numbers were 72 (1 mg), 61 (3 mg), 74 (10 mg), and 55 (placebo). The trial also measured quality of life using a standard questionnaire scored from 0 (worst imaginable health) to 100 (best imaginable health). The reported data shows average scores at the start of the study were around 56–59 across all groups, and at the end of 8 weeks they were approximately 67–72, with similar figures seen across all four groups including placebo. A planned sub-group analysis looking at female participants separately reported that 32, 35, and 37 women in the 1 mg, 3 mg, and 10 mg groups respectively met the main response standard, compared with 19 women in the placebo group. Among male participants, the reported responder numbers were 13, 11, and 18 for the three ibodutant doses, and 20 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00948818 · results posted 30 January 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 397 people in the placebo group and 406 people in the linaclotide group — 803 participants in total. The trial was measuring whether linaclotide, compared to a dummy pill (placebo), made a difference to two key symptoms of irritable bowel syndrome with constipation (IBS-C): abdominal (tummy) pain, and the number of "complete spontaneous bowel movements" (CSBMs) — that is, bowel movements that happened without laxatives and left the person feeling fully emptied. By the end of the 12-week treatment period, 335 placebo participants and 312 linaclotide participants had completed the trial. The reported data shows the following numbers for the main (primary) outcomes. For the combined tummy-pain-and-bowel-movement goal — meeting both targets in at least 9 out of 12 weeks — 49 out of 356 linaclotide participants met this measure, compared with 20 out of 375 placebo participants. For the bowel-movement-only goal (at least 3 complete bowel movements per week, up by at least 1 from their starting point, for 9 of 12 weeks), 79 out of 326 linaclotide participants met this measure, versus 25 out of 370 placebo participants. For the tummy-pain-only goal (a 30% or greater reduction in pain score for 9 of 12 weeks), 139 out of 266 linaclotide participants met this measure, compared with 107 out of 288 placebo participants. A looser version of the combined goal — met in 6 out of 12 weeks rather than 9 — was reached by 136 out of 269 linaclotide participants and 83 out of 312 placebo participants. The reported data also shows two secondary (additional) outcomes. Over the 12-week period, linaclotide participants recorded an average of about 2.3 complete spontaneous bowel movements per week, compared with about 0.7 in the placebo group. For all spontaneous bowel movements (not just "complete" ones), the reported average was about 3.9 per week for linaclotide participants and about 1.1 per week for placebo participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00761007 · results posted 1 October 2010
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called ibodutant, tested at three different doses (10 mg, 30 mg, and 60 mg), compared against a placebo (a dummy treatment with no active ingredient) in people with irritable bowel syndrome (IBS). A total of 554 people were enrolled across the four groups, and the trial was measuring whether participants reported satisfactory relief of their overall IBS symptoms over a four-week period. The reported data shows that for the main (primary) outcome — defined as saying "yes" to feeling satisfactory symptom relief in at least 2 out of 4 weeks — 79 participants in the 10 mg ibodutant group, 61 in the 30 mg group, and 61 in the 60 mg group reported this level of relief, compared with 78 participants in the placebo group. For a stricter version of the same measure (relief in at least 3 out of 4 weeks, a secondary outcome), the numbers were 53, 39, and 37 participants across the three ibodutant doses respectively, compared with 48 in the placebo group. The reported data also shows results for a smaller subgroup of participants who had a diarrhoea-predominant form of IBS: in that subgroup, 33, 17, and 22 participants across the three doses reported relief under the stricter rule, compared with 25 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.