Status:
RECRUITING
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
Lead Sponsor:
Biokuris s.a.
Conditions:
Irritable Bowel Syndrome-like Symptoms
Crohn Disease Remission
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06104631
Start Date
March 12 2024
End Date
October 1 2025
Last Update
May 2 2025
Active Locations (2)
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1
CHU Liege - Gastroenterology
Liège, Belgium, 4000
2
CHU Lille - Gastroenterology
Lille, France, 59000