Irritable Bowel Syndrome Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old, of any gender.
• People who are willing and able to sign a consent form and follow the study procedures.
• People who are willing to keep their diet and physical activity the same throughout the study.
• People who are able to swallow a large capsule (about 23mm long and 9mm wide — roughly the size of a large supplement pill).
• People who have been diagnosed with one of the following gut conditions (using a specific diagnostic system called Rome IV): functional abdominal bloating or distension (FABD), functional diarrhea, mixed-type irritable bowel syndrome (IBS-M), or diarrhea-predominant irritable bowel syndrome (IBS-D).
• People who experience significant abdominal bloating or distension, rated 3 or more out of 10 on average over a week.
• People who have had a specific breath test (called a Lactulose Hydrogen Breath Test) that showed an abnormal result, indicating a possible overgrowth of bacteria in the small intestine (confirm with trial site for exact test details).

Who may not be able to join:

• People who typically have fewer than three bowel movements per week.
• People diagnosed with constipation-predominant irritable bowel syndrome (IBS-C).
• People with a history of certain gut diseases, gut surgeries, or radiation treatment to the abdomen or pelvis that could cause narrowing or blockage in the intestines — for example, conditions such as achalasia, eosinophilic esophagitis, inflammatory bowel disease, or previous surgery on the esophagus, stomach, small intestine, or colon. (Appendix or gallbladder removal more than 3 months before the screening visit may be acceptable — confirm with trial site.)
• People who have a central venous catheter (a tube placed into a large vein).
• People with known structural problems in the gut, such as narrowings or abnormal connections (fistulas) that cause blockages.
• People with a known history of radiation treatment to the abdomen.
• People who have taken certain medications in the week before the screening visit that can significantly affect gut movement — such as opioid painkillers, anticholinergic drugs, or GLP-1 medications — unless those medications are part of their regular ongoing treatment. Laxative use may be acceptable if used fewer than 3 times per week and kept unchanged. Certain stomach acid medications (proton pump inhibitors) may be allowed with a specific pause in use before and after the study capsule is swallowed (confirm with trial site).
• People currently using prokinetic medications (drugs that help move food through the gut), unless a 2-week period without those medications has been completed and the person is willing to avoid them for the whole study.
• People who are unable to stop using laxatives or prokinetic medications for 4 days before the breath test procedure.
• People with conditions that affect gut movement or function, such as gastroparesis (slow stomach emptying), intestinal pseudo-obstruction, systemic sclerosis, or Ogilvie's syndrome.
• People with celiac disease, whether treated or untreated.
• People with significant heart, liver, lung, kidney, blood, hormonal, or nervous system disease that, in the investigator's opinion, could affect safety or study results.
• People who have been diagnosed with or treated for cancer in the past year (non-melanoma skin cancers may be acceptable — confirm with trial site).
• People with inflammatory bowel diseases, including ulcerative colitis, Crohn's disease, or microscopic colitis.
• People with IBS who also have warning signs such as rectal bleeding, unexplained weight loss, iron deficiency anaemia, or symptoms that wake them at night.
• People aged 50 or older who have not had either a negative stool-based bowel cancer screening test within the last 2 years, or a colonoscopy within the last 10 years that was clear of colorectal cancer.
• People with a diagnosis of epilepsy.
• People with a history of immune system conditions, infectious diseases, or conditions that weaken the immune system — such as hepatitis, tuberculosis, HIV, Parkinson's disease, multiple sclerosis, AIDS, lymphoma, or long-term steroid use — if the investigator believes this would affect safety or results.
• People with a history of difficulty swallowing or any swallowing disorder that could create a risk of accidentally inhaling the capsule.
• People who have taken antibiotics (other than topical/skin use) within the 12 weeks before screening. Eligibility may be possible once a 12-week period without antibiotics has been completed.
• People who have regularly used probiotics, prebiotics, or synbiotics — including probiotic foods, drinks, or yogurts with live cultures — within 1 month before screening. Eligibility may be possible once a 1-month period without these has been completed.
• People who have previously had a faecal microbiota transplant (a procedure involving transfer of gut bacteria from a donor).
• People who are pregnant or breastfeeding.
• People who are planning to become pregnant during the study period.
• People with alcohol or drug misuse.
• People with a known allergy to any ingredients in the study capsules.
• People who do not speak English.
• People who have an MRI scan scheduled at any point during the study period. Eligibility may be possible once the MRI has been completed.

Important: Always verify eligibility with the trial site directly before applying.