Fecal Microbiota Transplant as Maintenance in Crohn's Disease After Anti-TNF Stop
Tests stool bacteria transplant versus a sham procedure in adults with Crohn's disease.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Caen Cedex 9, Clermont-Ferrand, Creteil Cedex, Le Kremlin-Bicetre, Montpellier Cedex 5, Nantes, Nice, Paris, Paris Cedex 12, Pessac, Pierre-Bénite, Rennes Cedex 9, and Toulouse Cedex 9, FranceSee the 13 sites
- Registry title
- Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 150 people, planned
- Started
- 22 Sept 2021
- Expected to end
- 22 Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Fecal Microbiota Transplantation (FMT)
- Sham-transplantation (placebo)
- Record updated
- 11 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease who have been in remission for at least 6 months on an anti-TNF drug and are willing to stop it. It tests fecal microbiota transplantation as ongoing treatment after stopping.
- Age
- 18 to 74 years (patients); 18 to under 50 years (healthy donors)
- Sex
- All sexes
- Disease stage
- Crohn's disease for at least 6 months, in steroid-free clinical remission for at least 6 months, with CDAI <150 the week before inclusion
- Earlier treatment
- Must be taking an anti-TNF agent with no change in Crohn's treatment in the last 6 months, and be willing to stop the anti-TNF treatment
Main reasons for not taking part
- Crohn's complication that needs surgery
- Crohn's disease only in the upper digestive tract
- Active perineal disease (abscess, draining fistula, seton or ulceration)
- More than one small bowel resection, or more than 1 meter of small intestine removed
- Pregnancy or breastfeeding during the study
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- 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
- Crohn's Disease complication requiring surgical treatment
- 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
- Contraindication to colonoscopy or anesthesia
- Pregnancy or breastfeeding during the study (Cf. Addendum 4)
- Participation in any other interventional study
- Patient under legal protection
- For details, please see protocol
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Where in France
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranceTaking people
- Assistance Publique Hopitaux De ParisCreteil Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
- Hopital Haut-LevequePessac, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.
The 2 groups in the trial
- Fecal microbiotaTreatment being tested
Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation (endoscopic and oral)
Treatment: Fecal Microbiota Transplantation (FMT)
- Sham-transplantationSham treatment, for comparison
Patients receiving the sham-transplantation in 3 times after inclusion and randomisation (endoscopic and oral)
Treatment: Sham-transplantation (placebo)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
- Plain-language title
- Fecal Microbiota Transplant as Maintenance in Crohn's Disease After Anti-TNF StopGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04997733, who can take part
- Record updated
- 11 August 2025