Using fecal microbiota transplantation to maintain remission in Crohn's disease after stopping anti-TNF treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of fecal microbiota transplantation (FMT) as a maintenance treatment for patients with Crohn's disease who are in remission after withdrawing from anti-TNF therapy. The trial aims to restore a healthy gut microbiota in patients whose condition is characterized by an inappropriate immune response and altered gut microbiota. Participants will receive either FMT or a sham treatment to assess the clinical outcomes over a specified period. The study is designed to address the lack of specific recommendations for Crohn's disease patients in remission under anti-TNF agents.

Why it matters

Who can join: the full rules

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's running

• Gastroenterology Department of Saint Antoine Hospital
  Paris, France Recruiting

Study contacts

• Principal investigator: Harry SOKOL, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Harry SOKOL, PU-PH
• Email: harry.sokol@aphp.fr
• Phone: 01 49 28 31 62

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.