NCT06104631

A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms

A 10-week Randomized Double-blinded Crossover Trial of BiOkuris® Chitin-glucan Based Formulation Versus Placebo in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Biokuris s.a. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease is a chronic and complex inflammatory bowel disease affecting the gastrointestinal tract, causing symptoms like abdominal pain, diarrhea, and fatigue. While its exact cause is unclear, it involves genetic, environmental, and immunological factors. Crohn's disease can lead to nutrient deficiencies and has unpredictable flare-ups and remission periods. During the remission phases, irritable bowel syndrome (IBS)-like symptoms can persist in 50% of patients, for which no satisfactory treatment is available yet. Chitin-glucan is prebiotic, obtained by extraction, isolation and purification from a fungal resource: the mycelium of Aspergillus niger (a microscopic fungus of the Ascomycetes family) of which it composes the cell walls. The biopolymer consists essentially of two types of polysaccharide chains: chitin (poly-N-acetyl-D-glucosamine) and beta-(1,3)-D-glucan (D-glucose units linked essentially via beta-1,3 bonds). Because of its beta bond, human intestinal enzymes cannot digest it, as a result, the majority of chitin-glucan can reach the colon where it can be fermented by the microbiota. By modulating the composition and/or activity of the intestinal microbiota, fermentation of chitin-glucan could have beneficial effects on health. The aim of the RELIEVE study is to assess if BK003 could improve the relief of global symptoms, individual symptoms, stool consistency and frequency of evacuations, quality of life, anxiety, and depression in patients with Crohn's disease in remission without treatment or with stable maintenance therapy and having IBS-like symptoms and to confirm the product's safety.

Conditions

• Irritable Bowel Syndrome-like Symptoms
• Crohn Disease Remission

Interventions

Type	Name	Description
OTHER	BK003	The product is a combination of chitin-glucan and other dietary complement components. The dosage of chitin-glucan is 3 g/day. The product is a powder for oral administration 1x/day.
OTHER	Placebo	The placebo product has the same composition in excipient, same form and same posology as BK003.

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2023-10-27
• Last updated: 2025-05-02

Locations

2 sites across 2 countries: Belgium, France