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New treatment option for Irritable Bowel Syndrome-like Symptoms
Official title A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
ClinicalTrials.gov ID: NCT06104631
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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,
You likely can't join if
- Patients with other concomitant organic gastrointestinal abnormalities besides Crohn's disease: ano-perineal lesions, extra-intestinal manifestations...
- 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.)...
- 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,
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Liège, Belgium
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liège, Belgium; Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.