Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
Recruiting · NCT04997733 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
Fecal Microbiota Transplantation (FMT)Sham-transplantation (placebo)
What this trial is about
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.
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Gastroenterology Department of Saint Antoine Hospital - Paris, France