Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT04997733
• Date of registration: 05/07/2021
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal MIRACLE
• Scientific title: Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
• Date of first enrolment: September 22, 2021
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04997733
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Harry SOKOL, PU-PH
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Harry SOKOL, PU-PH

• Name: Harry SOKOL, PU-PH

Key inclusion & exclusion criteria

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 minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Fecal Microbiota Transplantation (FMT)

Drug: Sham-transplantation (placebo)

Primary Outcome(s)

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 for at least 6 months under anti-TNF agent [Time Frame: 52 weeks after FMT or sham-transplantation]

Secondary Outcome(s)

Relapse free survival [Time Frame: 52 weeks after FMT or sham-transplantation]

Secondary ID(s)

APHP190183

2019-003816-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CRB-HUEP

Institut National de la Santé Et de la Recherche Médicale, France