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:

• You are between 18 and 65 years old (male or female)
• You have been diagnosed with Irritable Bowel Syndrome (IBS) following recognised medical guidelines, meaning you have had recurring stomach pain at least once a week for the past 3 months, linked to changes in your bowel habits, and your symptoms started at least 6 months ago
• Your IBS is the diarrhoea-predominant type (IBS-D), meaning most of your loose or watery stools happen more than 25% of the time, and hard or lumpy stools happen less than 25% of the time
• Other conditions that could explain your symptoms have been ruled out by a doctor
• In the week before joining the study, you had at least 4 days with loose or watery stools
• Your stomach pain has been rated at least 3 out of 10 on average in the week before joining the study
• You completed an electronic daily symptom diary on at least 11 out of 14 days during the initial screening period
• You are willing and able to follow all study requirements
• You have signed a consent form agreeing to take part
• If you are a woman who could become pregnant, you have a negative pregnancy test at the start and agree to use reliable contraception throughout the study and for at least one full contraceptive cycle after

Who may not be able to join:

• You have a significant ongoing health condition affecting the heart, kidneys, nervous system, hormones, metabolism, or liver, or you have abnormal blood test results considered clinically important
• You have a known hole (perforation) or blockage in your digestive tract
• You have been diagnosed with a confirmed digestive disease such as coeliac disease, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), bile acid malabsorption, or similar conditions
• You have other conditions affecting how your gut moves food through, such as gastroparesis or narcotic bowel syndrome
• You have had major abdominal surgery (some minor surgeries are allowed, but not if they were within 6 months before screening)
• You currently have or have had cancer of any type, with some exceptions — people whose cancer was fully removed with no signs of return for at least 5 years and who have had no treatment may be allowed (confirm with trial site)
• You are allergic or sensitive to any ingredients in the study product
• You are currently using a product called Gelsectan®
• You have used certain anti-diarrhoea or gut-relaxing medicines (such as loperamide or antispasmodics) in the 14 days before joining the study
• You are using certain medicines that affect gut pain, stool habits, or gut lining — including strong painkillers, certain anti-nausea drugs, steroids, or immune-suppressing treatments (confirm with trial site for full list)
• You have used probiotics, prebiotics, or the antibiotic rifaximin in the 28 days before joining the study
• You have an unstable major psychiatric condition or eating disorder, or you take antidepressants or anti-anxiety medicines unless you have been on a steady dose for at least 6 weeks before joining
• You have misused laxatives in the past 5 years
• You have had issues with alcohol or drug misuse in the past 12 months
• You have taken part in another clinical trial or used an experimental treatment within 30 days before joining
• You are pregnant, breastfeeding, or planning to become pregnant during the study

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