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

Inclusion Criteria:

1. Adult females and males, aged 18-75 years,
2. Diagnosis of IBS at least 6 months prior to study entry,
3. Confirmed IBS according to Rome-IV criteria (as determined by investigator),
4. Patient having either constipation (IBS-C), diarrhoea (IBS-D) or alternance ofconstipation/diarrhoea (IBS-M),
5. Possession of a digital device (i.e., smartphone or tablet),
6. Patient who read, understood, and signed the informed consent form (ICF),
7. Patient willing to adhere to the study visit schedule and capable to understand andcomply with protocol requirements and product intake,
8. Male, or female patient of childbearing potential, who agrees to use acceptable birthcontrol methods throughout the study period. As assessed at the end of the run-in period, week 2 :
9. Patient with a baseline score for abdominal pain ≥ 2 and < 6 assessed on a 7-pointLickert scale
10. Patient with correct and complete reporting of the study questionnaires and scoresduring the run-in period (≥75% completion)

Exclusion Criteria:

1. Severe gastrointestinal pathologies other than IBS, including: ulcers, coeliacdisease, inflammatory bowel disease, bowel cancer, bowel resection, auto-immunediseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiplesclerosis, Graves' disease), bariatric surgery, acute or chronic diarrhoea secondaryto confirmed infectious gastroenteritis, or enteral or parenteral nutrition,
2. Metabolic disorders affecting intestinal transit function or nutrient absorptionincluding uncontrolled diabetes and uncontrolled dysthyroidism,
3. Patients experiencing complications of abdominal radiotherapy,
4. Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior tostudy entry, or planned during the study; appendectomy within 6 months prior to studyentry,
5. Galactose intolerance ,
6. Use of opioids or narcotic analgesics within 6 weeks prior to week 0,
7. Systemic antibiotic treatment in progress or prescribed less than 4 weeks prior tostudy entry,
8. 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,
9. Use of laxatives, antibloating agents, antidiarrheal medication, antispasmodics,anxiolytics, antidepressants, analgesics, and non-steroidals anti-inflammatory drugsif started less than 2 months prior to week 0 . These medications are authorized ifconsumed for longer than 2 months before week 0 and maintained at a stable dosage forthe entire study duration,,
10. 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 lessthan 1 month prior to week 0. These diets are authorized if followed for longer than 2months before week 0 and maintained for the entire study duration,,
11. Excessive alcohol consumption (more than 10 units per week) and/or drug abuse,
12. Pregnancy and lactation, or plan to become pregnant during the study period,
13. Participation in other studies involving investigational or marketed productsconcomitantly or less than 3 months prior to study entry,
14. Known hypersensitivity to any of the ingredients or excipients of the investigationalproducts,
15. Patient who has forfeited their freedom by administrative or legal award, or who isunder guardianship or under limited judicial protection. As assessed at the end of the run-in period, week 2 :
16. Use of opioids or narcotic analgesics during the run-in period (between week 0 andweek 1),
17. Systemic antibiotic treatment in progress or prescribed during the run-in period (between week 0 and week 1),
18. Deviation from lifestyle and dietary recommendations to be followed during the study (between week 0 and week 1).