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

Recruiting

• Conditions: Crohn’s disease

• Registration Number: 2024-511822-30-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-29
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

Crohn’s Disease complication requiring surgical treatment

Contraindication to colonoscopy or anesthesia

Pregnancy or breastfeeding during the study

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.		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 (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.

Secondary Outcome Measures

Name	Time	Method
Relapse free survival rate from week 0 (V2) to week 52 (V8)		Relapse free survival rate from week 0 (V2) to week 52 (V8)
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)		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)
Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2.		Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2.
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)		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)
Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)		Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)

Trial Locations

Locations (15)

Assistance Publique Hopitaux De Paris; 🇫🇷 Creteil Cedex, France

Hospices Civils De Lyon; 🇫🇷 Pierre Benite, France

Hopital Saint Antoine; 🇫🇷 Paris Cedex 12, France

CHRU De Nancy; 🇫🇷 Vandoeuvre Les Nancy, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Centre Hospitalier Universitaire Amiens Picardie; 🇫🇷 Amiens Cedex 1, France

Centre Hospitalier Universitaire De Toulouse; 🇫🇷 Toulouse Cedex 9, France

Centre Hospitalier Universitaire De Caen Normandie; 🇫🇷 Caen Cedex 9, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes Cedex 9, France

Les Hopitaux Universitaires De Strasbourg; 🇫🇷 Strasbourg Cedex, France

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Assistance Publique Hopitaux De Paris

🇫🇷Creteil Cedex, France

Frank CARBONNEL

Site contact

0145213722

franck.carbonnel@aphp.fr

Francisca JOLY

Site contact

0140812362

francisca.joly@aphp.fr

Matthieu ALLEZ

Site contact

0142499597

matthieu.allez@aphp.fr

Mathieu UZZAN

Site contact

0149812362

mathieu.uzzan@aphp.fr