A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome

Inclusion criteria

• Adult females and males, aged 18-75 years,
• Diagnosis of IBS at least 6 months prior to study entry,
• Confirmed IBS according to Rome-IV criteria (as determined by investigator),
• Patient having either constipation (IBS-C), diarrhoea (IBS-D) or alternance of constipation/diarrhoea (IBS-M),
• Possession of a digital device (i.e., smartphone or tablet),
• Patient who read, understood, and signed the informed consent form (ICF),
• Patient willing to adhere to the study visit schedule and capable to understand and comply with protocol requirements and product intake,
• Male, or female patient of childbearing potential, who agrees to use acceptable birth control methods throughout the study period.

As assessed at the end of the run-in period, week 2 :

• Patient with a baseline score for abdominal pain ≥ 2 and < 6 assessed on a 7-point Lickert scale
• Patient with correct and complete reporting of the study questionnaires and scores during the run-in period (≥75% completion)

Exclusion criteria

• Severe gastrointestinal pathologies other than IBS, including: ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, auto-immune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, Graves' disease), bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition,
• Metabolic disorders affecting intestinal transit function or nutrient absorption including uncontrolled diabetes and uncontrolled dysthyroidism,
• Patients experiencing complications of abdominal radiotherapy,
• Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior to study entry, or planned during the study; appendectomy within 6 months prior to study entry,
• Galactose intolerance ,
• Use of opioids or narcotic analgesics within 6 weeks prior to week 0,
• Systemic antibiotic treatment in progress or prescribed less than 4 weeks prior to study entry,
• Use of products marketed as or rich in prebiotics, probiotics, or symbiotics (e.g., kefir, probiotic yogurt, baker's yeast, etc.) less than 2 weeks prior to week 0,
• Use of laxatives, antibloating agents, antidiarrheal medication, antispasmodics, anxiolytics, antidepressants, analgesics, and non-steroidals anti-inflammatory drugs if started less than 2 months prior to week 0 . These medications are authorized if consumed for longer than 2 months before week 0 and maintained at a stable dosage for the entire study duration,,
• Diets including low-FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets if started less than 2 months prior or stopped less than 1 month prior to week 0. These diets are authorized if followed for longer than 2 months before week 0 and maintained for the entire study duration,,
• Excessive alcohol consumption (more than 10 units per week) and/or drug abuse,
• Pregnancy and lactation, or plan to become pregnant during the study period,
• Participation in other studies involving investigational or marketed products concomitantly or less than 3 months prior to study entry,
• Known hypersensitivity to any of the ingredients or excipients of the investigational products,
• Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.

As assessed at the end of the run-in period, week 2 :

• Use of opioids or narcotic analgesics during the run-in period (between week 0 and week 1),
• Systemic antibiotic treatment in progress or prescribed during the run-in period (between week 0 and week 1),
• Deviation from lifestyle and dietary recommendations to be followed during the study (between week 0 and week 1).