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Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal (MIRACLE)
EU CTIS ID: 2024-511822-30-00
What this study is testing
Evaluate the clinical efficacy at week 52 (V8) of FMT versus sham transplantation as a maintenance treatment following anti-TNF agent withdrawal in patients with Crohn’s disease in steroid-free clinical remission for at least 6 months under anti-TNF agent.
- Phase III and phase IV (Integrated)
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
- Age ≥ 18 years and < 75 years
- Crohn’s disease (according to the Lennard-Jones criteria) for at least 6 months
- Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn’s disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI <150 the week before inclusion) and willing to withdraw anti-TNF treatment
- Female of child-bearing age with an active contraception and this during at least the period of treatment
- Patient with health insurance
- Informed Written consent
You likely can't join if
- Crohn’s Disease complication requiring surgical treatment
- Contraindication to colonoscopy or anesthesia
- Pregnancy or breastfeeding during the study
- Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)
- History of more than one small bowel resection or small intestine resection > 1 meter
See the full eligibility criteria
- Age ≥ 18 years and < 75 years
- Crohn’s disease (according to the Lennard-Jones criteria) for at least 6 months
- Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn’s disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI <150 the week before inclusion) and willing to withdraw anti-TNF treatment
- Female of child-bearing age with an active contraception and this during at least the period of treatment
- Patient with health insurance
- Informed Written consent
- Healthy volunteers donors :Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
- Crohn’s Disease complication requiring surgical treatment
- Contraindication to colonoscopy or anesthesia
- Pregnancy or breastfeeding during the study
- Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)
- History of more than one small bowel resection or small intestine resection > 1 meter
- 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.
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, 65+ 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.