Phase 3 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:

• You are aged 18 to 65 years old (male or female)
• You have been diagnosed with Irritable Bowel Syndrome (IBS) — any type except the constipation-dominant type — based on recognised medical criteria (called Rome IV)
• Your IBS symptoms are rated at a moderate-to-severe level based on a standard symptom score (confirm with trial site)
• You are willing and able to keep your normal eating habits throughout the study
• You are able to understand the study requirements and are willing to sign a consent form
• If you are a woman who could become pregnant, you are willing to use an acceptable form of birth control throughout the study

Who may not be able to join:

• You have been diagnosed with constipation-dominant IBS (IBS-C)
• You have had more than 5 bowel movements per day on average during the initial screening period
• You have a serious illness or gut condition other than IBS, such as stomach ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, or a confirmed infectious gut illness
• You have had abdominal surgery (with some exceptions like appendix removal or caesarean section carried out more than 6 months ago — confirm with trial site)
• You have a family condition affecting the bowel, such as Lynch syndrome or Familial Adenomatous Polyposis
• You have had a faecal transplant in the 6 months before the study screening
• You have taken probiotic, prebiotic, or synbiotic supplements within the 2 weeks before screening, or are unwilling to stop them during the trial (note: regular yogurt or cheese with live cultures is generally acceptable)
• You have taken antibiotics or antifungal medicines within the 2 weeks before being assigned to a treatment group, or would need to take them during the study
• You have used laxatives, anti-bloating, anti-diarrhoea, or gut-spasm medicines within 2 weeks before screening, or would need them regularly during the study (a specific rescue medicine called loperamide may be permitted — confirm with trial site)
• You regularly take anti-inflammatory painkillers (such as ibuprofen) at doses higher than a low-dose aspirin for heart protection, within 2 weeks before screening or during the study
• You have used strong painkillers such as opioids, tramadol, or codeine within 6 weeks before screening, or would need them during the study
• You are currently taking two or more antidepressant, anti-anxiety, or antipsychotic medicines, or your dose of a single such medicine has not been stable for at least 3 months
• You have taken certain bladder medicines (anticholinergics) within 1 week before screening or would need them during the study (confirm with trial site for specific drug names)
• You have an allergy to yeast (especially Saccharomyces boulardii) or a known sensitivity to any ingredient in the study product
• You have a central venous catheter, are critically ill, or have a weakened immune system
• You have a rare inherited condition affecting how your body handles certain sugars, such as lactose, galactose, fructose, or sucrose (confirm with trial site)
• You drink more than 7 units of alcohol per week or misuse drugs
• You have any other health condition or are taking other treatments that the study doctor believes could affect the study results
• You are pregnant, breastfeeding, or at risk of becoming pregnant
• You are currently under legal guardianship or court protection, or your freedom is restricted
• You are currently taking part in another clinical trial that could affect this study's results, or have recently finished one (confirm with trial site regarding timing)
• Your current health does not allow you to give informed consent

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