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
Conditions
Interventions
Product Name: Fecal microbiota
Pharmaceutical Form: Rectal solution
Pharmaceutical form of the placebo: Rectal solution
Route of administration of the placebo: Rectal use
Product Name: Fecal microbio
Sponsors
ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients : -Age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the clinical efficacy at week 52 (V8) 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.;Secondary Objective: Comparison between FMT and sham-transplantation on : a.Relapse free survival between week 0 (V2) and 52 (V8) b.Mucosal healing at week 52 (V8) c. Clinical and endoscopic remission at week 52 (V8) d. Changes in inflammation at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8) e. Changes in intestinal microbiota composition at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8) Objective of any potential ancillary study : - Identify potential microorganisms in healthy volunteers donor’s microbiota associated with positive and negative outcome. - Identify blood biomarkers and metabolites associated with maintenance of clinical remission. ;Primary end point(s): Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline over 2 consecutive weeks and the need to start any new treatment for CD. ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a.Relapse free survival rate from week 0 (V2) to week 52 (V8) b.Proportion of endoscopic remission (SES-CD =2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8) c.Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD = 2. d.Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8) e.Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8) ;Timepoint(s) of evaluation of this end point: week 0 (V2) to week 52 (V8) | — |
Countries
France
Contacts
Public ContactDRCI Hôpital Saint Louis
ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed