Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS

Exclusion Criteria

• •1. Known allergy or hypersensitivity to the components of the investigational product.
• •2. Smokers
• •3. Lactose or fructose intolerance.
• •4. Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ to 160 mmHg and diastolic blood pressure ≥ to 100mmHg.
• •5. History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
• •6. History of malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
• •7. History and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., inflammatory bowel disease, coeliac disease, Clostridium difficile colitis, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc.)
• •8. Major gastric, hepatic, biliary, pancreas or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \> 3 months prior to study screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \> 3 months prior to screening).
• •9. Clinically significant findings in colonoscopy within the 3 years prior to study.
• •10. Family history among first degree relatives of colorectal cancer or inflammatory bowel disease.
• •11. Individuals diagnosed with psychiatric disease (e.g., bipolar disorder, Schizophrenia) with or without medication in the last three years.
• •12. Individuals currently on medication for anxiety and/or depression
• •13. Individual has a history and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the participants, e.g.:
• •1. thyroid gland disorder
• •2. hypertension
• •3. diabetes mellitus
• •4. eating disorder
• •5. immunodeficiency
• •6. relevant gynecological or urological disorder
• •7. any other relevant serious organ or systemic diseases ( e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc.)
• •14. Regular medication and/or supplementation within the last month prior to and planned during the study:
• •1. antibiotics, probiotics, prebiotics within 4 weeks before enrollment for screening.
• •2. medication for IBS complaints, e.g., bile acid binders (cholestyramine), rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide
• •3. which could influence gastrointestinal functions (e.g., laxatives, opioids, systemic corticosteroids, anti-cholinergics, anti-diarrheals, proton pump inhibitors, H2-blockers, etc.) as per investigator judgement. Exception: ad hoc use of Macrolits.
• •15. Regular use of psychopharmaca (e.g., hypnotics / sedative drugs, anxiolytics, antidepressants, neuroleptics, anticonvulsants) within 3 months prior to study or adaptogens (e.g., ginseng, Ashwagandha, satavari, St. John's Wort) within 6 weeks prior to and during the study.
• •16. Introductions of a specific diet (e.g., low carb, vegan, high fibre, low FODMAP) within last 3 months prior to and during the study.
• •17. Women of child-bearing potential: pregnancy or nursing.
• •18. History of or current abuse of drugs, alcohol, tobacco/nicotine or medica tion.
• •19. Participation in another study during the last 30 days prior to and during the study.
• •20. Any other reason for exclusion as per investigator's judgment, e.g., insufficient compliance with study procedures.