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

Prior treatment

• 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.

Other illness

• Crohn’s Disease complication requiring surgical treatment
• Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, 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

Other

• Contraindication to colonoscopy or anesthesia
• Pregnancy or breastfeeding during the study

• 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
• Patient with health insurance
• Informed Written consent
• Healthy volunteers donors :Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day