Phase 2 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:

• The participant (and their parent, guardian, or legal representative) must agree to take part and sign the required consent forms before any study procedures begin.
• The participant must be a male or female aged 6 to 17 years (inclusive) who is being treated as an outpatient (not admitted to hospital).
• The participant must be able to read and understand a daily digital diary; for children aged 6 to 11 who cannot do this, a parent, guardian, or caregiver may complete it on their behalf after receiving training.
• Female participants must not be pregnant, breastfeeding, or planning to become pregnant during the study or for about 30 days after the last dose of the study drug, and must have negative pregnancy tests at two specific study visits.
• Female participants who are capable of becoming pregnant must use at least one (and possibly two, depending on local rules) approved method of birth control from the first day of the study until at least 30 days after the last dose of the study drug.
• The participant must have a diagnosis of diarrhoea-predominant irritable bowel syndrome (IBS-D) in children and adolescents, based on specific criteria: abdominal pain at least 4 days per month over at least 2 months, linked to changes in bowel habits or stool appearance, that cannot be fully explained by another medical condition, and with loose or watery stools making up more than 25% of bowel movements (and hard stools making up less than 25%), without the use of laxatives.
• The diagnosis criteria must have been present for at least 2 months before the first study visit, though a new diagnosis may be made by the study doctor at that visit.
• The participant must have completed the daily digital diary on at least 8 out of the 14 days before the randomisation visit (the visit where study treatment is assigned).
• The participant must have had an average daytime abdominal pain score of 1.0 or higher over the 2 weeks before randomisation.
• The participant must have had at least one daytime bowel movement with a very loose or watery consistency (Type 6 or Type 7 on the paediatric Bristol Stool Form Scale) on at least 2 days per week during the 2 weeks before randomisation, without using laxatives.

Who may not be able to join:

• People who do not have a gallbladder, either because they were born without one or because it was surgically removed.
• People who have had abdominal surgery within the 3 months before screening, or a history of major surgery on the stomach, liver, pancreas, or intestines (note: some minor or older surgeries may still be allowed — confirm with trial site).
• People with a history of chronic or severe constipation, complications from constipation, or known or suspected blockage of the digestive tract.
• People with a history of, or current diagnosis of, constipation with soiling (encopresis).
• People who meet the criteria for other types of IBS (constipation-type, mixed type, or unspecified) or functional constipation.
• People with a history of certain serious bowel conditions, including intestinal obstruction, bowel perforation, toxic megacolon, ischaemic colitis, or impaired blood supply to the intestines, among others.
• People with a documented history of liver impairment (classified as Child-Pugh Grade A, B, or C).
• People with a history of, or current diagnosis of, inflammatory bowel conditions such as Crohn's disease or ulcerative colitis.
• People with coeliac disease, or a positive blood test for coeliac disease that has not been ruled out by a tissue biopsy.
• People with any inherited or acquired condition that affects the body's ability to absorb nutrients properly (confirm with trial site).
• People who have had a confirmed digestive tract infection within 3 months before screening.
• People with a known intolerance to lactose or fructose that causes diarrhoea or abdominal pain, which could affect study results.
• People who have had diverticulitis (inflammation of pouches in the bowel) within 3 months before screening.

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