Phase 2 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 80 years old (inclusive)
• You have been diagnosed with a type of irritable bowel syndrome that causes diarrhea (IBS-D) or a mixed type with both diarrhea and constipation (IBS-M), based on recognised diagnostic guidelines called Rome IV criteria
• Your IBS has been rated as moderate or severe based on a standard symptom scoring assessment done at your screening visit
• During a lead-in period before the trial starts, your abdominal pain scored 4.0 or higher on average each week
• If you have IBS-D: you had at least one loose or watery stool on at least 2 days per week during the lead-in period
• If you have IBS-M: you had abnormal stools (either very hard/lumpy or loose/watery) on an average of 2 days per week during the lead-in period, with a specific mix of both types (confirm with trial site)

Who may not be able to join:

• You have been diagnosed with IBS that is mainly constipation (IBS-C) or an unclassified type of IBS (IBS-U)
• You have or have had an inflammatory or immune-related gut condition, such as inflammatory bowel disease, microscopic colitis, or coeliac disease
• You have had a confirmed gut infection within the last 3 months before your screening visit
• You have or have had a condition called bile salt diarrhoea
• You have a significant mental health diagnosis (such as schizophrenia, bipolar disorder, major depression, or panic disorder) that the trial doctor feels could affect the study, or you scored above 10 on a standard anxiety and depression questionnaire at screening
• You have previously tried more than two of the following types of treatment for IBS: certain antidepressants or nerve-calming medicines, certain antibiotics used for IBS, certain medicines that slow gut activity, certain opioid-based gut medicines, certain medicines that increase fluid in the gut, or certain medicines that speed up gut movement (confirm specific medicines with trial site)
• Your thyroid hormone levels were found to be abnormal at your screening blood test
• Your blood test came back positive for markers associated with coeliac disease
• Your stool test showed raised levels of a substance called calprotectin, which can indicate gut inflammation
• You have an abnormal heart rhythm measurement on your ECG, specifically a prolonged QT interval (confirm details with trial site)
• Your blood tests at screening showed abnormally high levels of certain liver enzymes (ALT or AST) or bilirubin
• You have a current or long-standing liver disease, a bile duct problem, or a condition called Gilbert's Syndrome

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