Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal

Phase 1

• Conditions: Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors; MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003816-29-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-14
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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 CD specific treatment and CDAI <150 the week before inclusion (Addendum 2)) 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 (AME except)
-Informed Written consent

Healthy volunteers donor : see protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Patient :
-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, stomac, duodenum, jejunum)
-History of bowel resection
-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
-Patients under legal protection.

Healthy volunteers donor : see protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified