Informations générales (source: ClinicalTrials.gov)
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2021
juillet 2029
18 septembre 2025
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.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:23:17 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
Critères
Tous
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
- 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