Crohn'sRecruiting
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Phase 3 · Testing Fecal Microbiota Transplantation (FMT) · 1 site · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation (FMT) (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.
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.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 74
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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…
Plus 8 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 150 participants are expected to take part.
- Start date: 2021-09-22.
- Main results expected around 2027-05-22 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Evaluate the clinical efficacy 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… (52 weeks after FMT or sham-transplantation)
In the researchers’ words
Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts.
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 | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | CRB-HUEP; Institut National de la Santé Et de la Recherche Médicale, France |
| Enrollment | 150 (estimated) |
| Start date | 2021-09-22 |
| Primary completion (est.) | 2027-05-22 |
| First posted | 2021-08-10 |
| Last updated | 2025-08-11 |
| Official title | Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal |
| ClinicalTrials.gov ID | NCT04997733 |
Interventions
- Fecal Microbiota Transplantation (FMT) (Drug)
The colonoscopy for FMT will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The pati… - Sham-transplantation (placebo) (Drug)
The colonoscopy for sham-transplantation will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration, 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general an…
Full eligibility criteria (from the record)
Inclusion Criteria for patients : * 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 (week 52) * Patient with health insurance * Informed Written consent Inclusion Criteria for healthy volunteer donor : * Age ≥ 18 years and < 50 years * 17 kg/m² < body mass index < 30 kg/m² * Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day * Subject with health insurance (AME excepted) * Informed written consent Exclusion Criteria for patients : * Crohn's Disease complication requiring surgical treatment * Contraindication to colonoscopy or anesthesia * Pregnancy or breastfeeding during the study (Cf. Addendum 4) * Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomach, 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 * Participation in any other interventional study * Patient under legal protection Exclusion Criteria for healthy volunteer donor : \- For details, please see protocol
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Department of Saint Antoine Hospital | Paris | 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.