Crohn'sRecruiting
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
Not applicable · Testing BK003 · 2 sites · Biokuris s.a.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing BK003. Condition(s) listed: Irritable Bowel Syndrome-like Symptoms and Crohn Disease Remission.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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),
Plus 13 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2024-03-12.
- Main results expected around 2025-08 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Belgium and France.
Main thing being measured
- 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))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Irritable Bowel Syndrome-like Symptoms; Crohn Disease Remission |
| Lead sponsor | Biokuris s.a. |
| Enrollment | 50 (estimated) |
| Start date | 2024-03-12 |
| Primary completion (est.) | 2025-08 |
| First posted | 2023-10-27 |
| Last updated | 2025-05-02 |
| 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 |
| ClinicalTrials.gov ID | NCT06104631 |
Interventions
- BK003 (Other)
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 (Other)
The placebo product has the same composition in excipient, same form and same posology as BK003.
Full eligibility criteria (from the record)
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.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Liege - Gastroenterology | Liège | Belgium | Recruiting |
| CHU Lille - Gastroenterology | Lille | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.