Phase 3 Irritable Bowel Syndrome Trial, Recruiting

Written by an AI model from the 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 who are willing to sign a consent form, follow the study rules, and complete a daily diary throughout the trial.
• People aged 18 to 70 years old (any gender).
• People who have been diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) based on recognised medical guidelines — meaning symptoms have been present for at least 6 months, with stomach pain on average at least one day per week over the past 3 months, and the pain is linked to changes in bowel habits or stool appearance, with loose or watery stools making up more than 25% of abnormal bowel movements.
• People who have had a colonoscopy within the 12 months before the study's run-in period, where the full bowel was examined and the results were either normal, showed only minor findings (such as small haemorrhoids or small polyps), or showed larger polyps that were treated so that only small ones remain (confirm with trial site).
• People whose colonoscopy or bowel examination was done at least 4 weeks before the run-in period, and who still had IBS symptoms before that period began.
• People who, during the run-in period, had loose or watery stools on an average of 4 or more days per week, and whose stomach pain on those days scored 3.0 or higher on a pain scale.
• People who completed their daily diary on at least 5 days in the week before being assigned to a treatment group, and on at least 10 days in the 2 weeks before that assignment.
• People who did not use any pain relief or rescue medications in the 14 days before being assigned to a treatment group.
• People who agree to keep their usual diet and lifestyle the same throughout the entire study period.

Who may not be able to join:

• People who have a constipation-type, mixed-type, or unclassified form of IBS.
• People who have a physical (organic) bowel disease — though certain minor findings such as mild gastritis without symptoms may still be considered eligible by the trial investigator (confirm with trial site).
• People who have digestive-related conditions affecting other organs, such as tuberculosis of the abdomen lining, pancreatitis, liver cirrhosis, or bile duct disease — though fatty liver that has not developed into hepatitis, and gallstones without symptoms, may be exceptions (confirm with trial site).
• People who are known to have lactose intolerance or coeliac disease.
• People who have other serious health conditions, including significant heart, lung, or kidney disease, cancer, autoimmune conditions, metabolic disorders (such as diabetes or thyroid problems), or certain reproductive system conditions (such as endometriosis or severe period pain requiring medication).
• People who have had previous abdominal or pelvic surgery — though appendix removal, caesarean section, tubal ligation without bowel complications, or hernia repair may be exceptions (confirm with trial site).
• People who have a diagnosed mental health condition, or moderate to severe depression or anxiety that requires medication, as measured by standard screening questionnaires.
• People whose stool test showed blood or white blood cells at a level the investigator considers clinically significant (certain causes such as haemorrhoids or menstruation may be exceptions — confirm with trial site).
• People who test positive for hepatitis C, HIV, syphilis, or hepatitis B and require antiviral treatment.
• People whose blood test results show significant abnormalities in kidney or liver function, as determined by the trial investigator.
• People with a history of drug or alcohol misuse.
• People who are unable to swallow solid tablets or capsules, even with the help of liquids.
• People who have a known allergy to the trial drug, the rescue medication, or any of their ingredients.
• People who are taking certain medications that affect gut movement or function and cannot stop them during the trial — including some antibiotics, probiotics, anti-diarrhoeal medications, opioids, or acid-reducing medications.
• People who are pregnant or breastfeeding.
• People who are unwilling or unable to use reliable contraception during the trial, or where the participant or their partner has a recent pregnancy plan.
• People who have taken part in another clinical trial and received an experimental drug or device within the 3 months before signing the consent form.
• People who have previously taken part in a clinical study of the drug SK08.
• People who the trial investigator considers unsuitable for participation for any other reason.

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