A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Placebo: The placebo product has the same composition in excipient, same form and same posology as BK003.
Study 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.
Eligibility
Primary outcome measure(s)
- Subject's global assessment (SGA) — at week 4 after randomization on period I (cross over) and at week 4 after wash-out period II (cross over)
Subjective global assessment of relief responder rate. SGA is scored on a 5-point Likert scale (1 = completely relieve and 5= being worse). Patients with an SGA of relief score from 1 to 3 is considered as responder.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Liege - Gastroenterology | Liège | Belgium | Recruiting |
| CHU Lille - Gastroenterology | Lille | France | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06104631 on ClinicalTrials.gov ↗ ← All trials in France