Investigating chitin-glucan for Crohn's disease patients with IBS-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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biokuris s.a. (industry)
• Locations: 2 sites (Liège and 1 other locations)
• Trial ID: NCT06104631 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a history of Crohn's disease in remission and experiencing IBS-like symptoms.

Not a fit: Patients with active inflammatory markers or those not meeting the IBS-like symptom criteria may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Liège and 1 other locations

• CHU Liege - Gastroenterology — Liège, Belgium (RECRUITING)
• CHU Lille - Gastroenterology — Lille, France (RECRUITING)

Study contacts

• Study coordinator: Salvatore Modica

Conditions: Irritable Bowel Syndrome-like Symptoms, Crohn Disease Remission, chitin-glucan, Crohn, IBS, Irritable Bowel Syndrome-like