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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Gastroenterology Department of Saint Antoine Hospital
RECRUITING
Paris
Contact Information
Primary
Harry SOKOL, PU-PH
harry.sokol@aphp.fr
01 49 28 31 62
Backup
Laurent BEAUGERIE, PU-PH
laurent.beaugerie@aphp.fr
laurent.beaugerie@aphp.fr
Time Frame
Start Date: 2021-09-22
Estimated Completion Date: 2029-07-22
Participants
Target number of participants: 150
Treatments
Experimental: Fecal microbiota
Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation (endoscopic and oral)
Sham_comparator: Sham-transplantation
Patients receiving the sham-transplantation in 3 times after inclusion and randomisation (endoscopic and oral)
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, CRB-HUEP
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov