NCT05780749

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Biokuris s.a. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DDI-IBS-001	The product is a combination of chitin-glucan and other dietary complement components. The dosage of chitin-glucan is 1.5 g/day. The product is a powder for oral administration 1x/day.
OTHER	DDDI-IBS-001 placebo	The placebo product has the same composition in excipient, same form and same posology as DDI-IBS-001.

Timeline

• Start date: 2023-11-23
• Primary completion: 2025-02-02
• Completion: 2025-02-02
• First posted: 2023-03-23
• Last updated: 2025-05-02

Locations

11 sites across 1 country: Belgium