A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome.
Irritable Bowel Syndrome (IBS) is a common chronic gastrointestinal condition that affects approximately 10-20% of adults in Western countries. IBS is a disorder with chronic or recurrent colonic symptoms without a clear-cut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION. Symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. Over 80% of individuals with IBS report food-related symptoms leading in the 70% of these patients to self-imposed food restrictions and/or modifications of their diet. These spontaneous unsupervised dietary modifications are associated with maladaptive eating patterns and unnecessary self-restricted diets, which could result in nutritional deficiencies. BiOkuris product DDI-IBS-001 is a food multicomponents product based on BiOkuris proprietary chitin-glucan complex. The objectives of the VITABIOTIC study is to confirm the effectiveness of the DDI-IBS-001 product in improving global symptoms, abdominal pain, stool consistency, quality of life, anxiety and depression in IBS patients and to confirm the product's safety.
• 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)