Actively Recruiting
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
Led by Biokuris s.a. · Updated on 2025-05-02
50
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged from 18 years to 75 years
- Long standing (>3 months prior to first visit) steroid-free clinical remission of Crohn's disease
- Clinical remission confirmed by clinical and biochemical assessments
- Absence of inflammatory markers at first visit
- Presence of IBS-like symptoms according to Rome IV criteria
- Abdominal pain score of 3 or higher on Likert scale at baseline
- Completion of at least 75% of study questionnaires during run-in period
- Stable medication use maintained at same dosage as last month before inclusion
- Stable use of anti-spasmodics, hypomotility agents, probiotics, prebiotics, bile-acid chelators, and anti-depressants if used for longer than 1 month before inclusion
- Agreement to maintain lifestyle behaviors during study
- Signed informed consent form
- Ability to communicate with investigator and comply with study procedures
- Possession of a digital device (smartphone or tablet)
- Willingness and ability to adhere to study visit schedule and product administration
- Use of acceptable birth control methods if of childbearing potential
- Ability to read and write in French
You will not qualify if you...
- Presence of other gastrointestinal abnormalities besides Crohn's disease (ano-perineal lesions, extra-intestinal manifestations, colorectal cancer history, abdominal radiotherapy, symptomatic intestinal stenosis)
- History of substance dependence
- Significant comorbidities such as unstable cardiovascular disease, complicated diabetes, or unstable thyroid function
- Use of non-steroidal anti-inflammatory drugs, steroids, opioids, or narcotic analgesics within the last month before baseline
- Starting diet or specific treatments for functional symptoms within one month before first visit
- Current or recent (within 2 weeks) antibiotic use
- Excessive alcohol consumption (>30 g/day for men, >20 g/day for women) or drug abuse
- Pregnancy, lactation, or planning pregnancy during study period
- Participation in other investigational or marketed product studies within 3 months prior to baseline
- Known hypersensitivity to study product ingredients or excipients
- Legal restrictions such as guardianship or limited judicial protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
CHU Liege - Gastroenterology
Liège, Belgium, 4000
Actively Recruiting
2
CHU Lille - Gastroenterology
Lille, France, 59000
Actively Recruiting
Research Team
S
Salvatore Modica
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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