BridgeMD
Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel
EU CTIS ID: 2024-513330-38-00
What this study is testing
Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For volunteers: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 km/m²
- Patients with IBD: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- Patients with IBD: Patient with health insurance (AME except)
- Patients with IBD: Informed Written consent
- For volunteers: For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence*) and this during at least the period of treatment (up to v2)
- For volunteers: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
You likely can't join if
- Healthy volunteers: Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration or history of abdominal surgery (except appendectomy).
- Patients with IBD: Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- Patients with IBD: Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion
- Healthy volunteers: Curative long-term treatment
- Patients with IBD: Participation in any other interventional study
- Patients with IBD: Patients under legal protection
See the full eligibility criteria
Who can join
- For volunteers: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 km/m²
- Patients with IBD: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- Patients with IBD: Patient with health insurance (AME except)
- Patients with IBD: Informed Written consent
- For volunteers: For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence*) and this during at least the period of treatment (up to v2)
- For volunteers: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- For volunteerss: - Patient with health insurance (AME except)
- For volunteers: Informed Written consent
- Patients with IBD: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 kg/m²
- Patients with IBD: Crohn’s Disease (Excepting disease involving only the upper GI tract) or ulcerative colitis (excepting disease involving only the rectum), according to the Lennard-Jones criteria for at least 6 months (15 patients with Crohn’s disease and 15 with ulcerative colitis will be recruited)
- Patients with IBD: Patient in steroid-free clinical remission for at least 6 months (for Crohn’s disease: CDAI <150 the week before inclusion, for ulcerative colitis: Partial Mayo Clinic score of 0 or 1).
- Patients with IBD: Female of child-bearing age with an active contraception. Efficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate <1%)
What rules you out
- Healthy volunteers: Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration or history of abdominal surgery (except appendectomy).
- Patients with IBD: Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- Patients with IBD: Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion
- Healthy volunteers: Curative long-term treatment
- Patients with IBD: Participation in any other interventional study
- Patients with IBD: Patients under legal protection
- Patient with IBD: Diagnosis of ulcerative colitis restricted to the rectum
- Healthy volunteers : Pregnant or breastfeeding women
- Healthy volunteers : blood donation in the 3 months before the study
- Healthy volunteers: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)
- Healthy volunteers : probiotics in the month preceding day 0 (V1)
- Healthy voluteers: contra-indications to the administration of gentamicin (refer to SmPC)
- Healthy volunteers: consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0
- Healthy volunteers: abdominal surgery in the past (except for appendectomy)
- Healthy volunteers: allergy against the antibiotics and antifungal treatment used in this study or to their excipients
- Healthy volunteers: fructose intolerance
- Patient with IBD: Fructose intolerance
- Healthy volunteers: Participation in any other interventional study
- Healthy volunteers: under legal protection
- Patients with IBD: Pregnant or breastfeeding women
- Patients with IBD: blood donation in the 3 months before the study
- Patients with IBD: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0
- Patients with IBD: probiotics in the month preceding day 0 and during the study
- Patients with IBD: Ileal resection > 50cm or colectomy
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.