Investigating chitin-glucan for Crohn's disease patients with IBS-like symptoms
Official title: 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
Run by Biokuris s.a. · NCT06104631 · Data updated 2026-11-12
This study is testing if a new treatment called chitin-glucan can help people with Crohn's disease who have IBS-like symptoms feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Biokuris s.a. Industry-sponsored |
| Locations | 2 sites (Liège and 1 other locations) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | August 2025 |
| Study ends | October 2025 |
| Registry record updated | May 2, 2025 |
| Trial ID | NCT06104631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with a history of Crohn's disease in remission and experiencing IBS-like symptoms.
✕Probably not a fit
Patients with active inflammatory markers or those not meeting the IBS-like symptom criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy of chitin-glucan in patients with Crohn's disease who are in remission but still experience irritable bowel syndrome (IBS)-like symptoms. The study will involve administering either the chitin-glucan treatment or a placebo to assess improvements in gastrointestinal symptoms. Participants will be closely monitored for their response to the treatment, with a focus on abdominal pain and overall symptom relief. The trial seeks to provide a potential new therapeutic option for a significant subset of Crohn's disease patients who currently lack satisfactory treatment.
Why it matters
Potential benefit: If successful, this trial could offer a new treatment option for Crohn's disease patients suffering from persistent IBS-like symptoms.
How similar studies have gone: While the use of chitin-glucan is a novel approach, similar studies targeting IBS-like symptoms in Crohn's patients have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients aged from 18 years to 75 years, * Long standing (\>3 months prior to V1) steroid-free clinical remission Crohn's disease according to clinical and biochemical assessments, * Clinical remission (according to the investigator), * Absence of inflammatory markers at V1, * Presence of IBS-like symptoms according to Rome IV criteria, * Likert scale ≥ 3 for abdominal pain at V0, * Patient with correct and complete reporting of the study questionnaires and scores during the run-in period (≥ 75% completion), * To continue all medication used in the last month before inclusion at the same dosage, * Anti-spasmodic, hypomotility agents, probiotics, prebiotics, bile-acid chelators, and anti-depressants are authorized if consumed for longer than 1 month before inclusion and maintained at a stable dosage for the entire study duration, * Agreeing to maintain their lifestyle behaviours during the participation in the study, * Patient has read, understood, and signed the informed consent form (ICF), * Patients capable of communicating with the investigator, replying to the questionnaires, and understanding the requirements and constraints of the study protocol, * Possession of a digital device (i.e., smartphone or tablet), * Patient willing to adhere to the study visit schedule and able to understand and comply with protocol requirements and product administration, * Male or female patient of childbearing potential who agrees to use acceptable methods of birth control (oral, transdermal, systemic contraception, intrauterine device, condom) for the duration of the study, * Patient can read and write in French. Exclusion Criteria: * Patients with other concomitant organic gastrointestinal abnormalities besides Crohn's disease: ano-perineal lesions, extra-intestinal manifestations of Crohn's disease, colorectal history of cancer or abdominal radiotherapy, symptomatic intestinal stenosis, substance dependence history, * Patients with significant comorbidities: instable cardiovascular diseases, complicated diabetes, instable thyroid function, * Patients receiving non-steroidal anti-inflammatory drugs, steroids, opioids, or narcotic analgesics in the last month before V0, * Patients beginning a diet or a specific treatment for functional symptoms (probiotics, prebiotics, anti spasmodic, chelators, anti-depressants, etc.) within one month before V1, * Ongoing antibiotics or antibiotics prescribed in the last 2 weeks before V1. * Excessive alcohol consumption (\>30 g/day \[i.e., 3 units/day\] for men and \>20 g/day \[i.e., 2 units/day\] for women) and/or drug abuse, * Pregnancy and lactation, or plan to become pregnant during the study period, * Participation in other studies involving investigational or marketed products concomitantly or less than 3 months prior to V0, * Known hypersensitivity to any of the ingredients or excipients of the study products, * Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
Where it's running
-
CHU Liege - Gastroenterology
Liège, Belgium Recruiting -
CHU Lille - Gastroenterology
Lille, France Recruiting
Study contacts
- Study coordinator: Salvatore Modica
- Email: s.modica@biokuris.com
- Phone: +32 4 259 85 00
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Understanding visceral sensitivity in IBS and IBD
This study is trying to understand how the body reacts to gut sensations in people with Irritable Bowel Syndrome, active and inactive Inflammatory Bowel Disease, and healthy individuals by collecting samples and measuring different body responses.
-
Examining a low sulfur diet for treating persistent symptoms in Crohn's disease
This study tests if a low sulfur diet can help people with Crohn's disease who still have symptoms feel better after 8 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.