Impact of the Fecal Flora Transplantation on Crohn's Disease

NCT02097797 | Completed DMC

• 1 other identifier: P 121104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.

Conditions

Crohn's Disease

Keywords

Inflammatory bowel disease; Crohn's disease; microbiota; fecal transplantation

Outcome Measures

Primary Outcomes (1)

• FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6.

  In other words, FT success is reached if the fecal microbiota of the receiver 6 weeks after FT is closer of the fecal microbiota of the donor that of the receiver before FT. Fecal microbiota composition will be assessed by 454 pyrosequencing (16S RNA) and microbiota comparison will be done using Sorensen's index.

  6 weeks after FT

Secondary Outcomes (10)

• FT feasibility

  6 weeks after FT

• Clinical relapse rate in the 24 weeks following FT procedure

  24 weeks following FT

• Effect of FT compared to sham transplantation on CRP

  6 weeks after FT

• Effect of FT compared to sham transplantation on Leukocytes level

  6 weeks after FT

• Effect of FT compared to sham transplantation on fecal calprotectin

  6 weeks after FT

Study Arms (2)

Fecal Transplantation

EXPERIMENTAL

patients receiving the fecal transplant (fecal microbiota from a healthy donor)

Other: Fecal Transplantation

Sham Transplantation

SHAM COMPARATOR

patients receiving the vehicle (Physiological serum)

Other: Sham Transplantation

Interventions

Fecal Transplantation OTHER

Fecal microbiota (50-100g of stool from donor resuspended in 250-350ml of physiological serum and filtered) given by infusion in coecum during colonoscopy

Fecal Transplantation

Sham Transplantation OTHER

250-350ml of physiological serum given by infusion in coecum during colonoscopy

Sham Transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 70 years
• Crohn's disease with colonic or ileo-colonic involvement
• Active disease at screening defined by a Harvey Bradshaw Index \>4
• Clinical remission (Harvey Bradshaw Index \<5) in the 3 weeks following corticosteroid onset
• Patient with health insurance
• Written consent obtained

You may not qualify if:

• Fistulizing disease
• Anoperineal or abdominal abscess
• Complication requiring surgical treatment
• Treatment with anti-TNFa (ongoing or stopped in the 1 month preceding randomization)
• Immunosuppressant treatment started or stopped in the 3 months preceding randomization
• Non-steroidal anti inflammatory drugs (NSAIDs) intake in the 4 weeks preceding randomization
• Antibiotics or antifungic treatment in the 4 weeks preceding colonoscopy
• Probiotics intake in the 4 weeks preceding colonoscopy
• Clostridium difficile infection in the 10 days preceding randomization
• contraindication to colonoscopy or anesthesia
• Pregnancy
• Donor
• Age \> 20 years and \< 50 years
• kg/m² \> BMI \> 17 kg/m²
• Regular bowel movement with usually one bowel movement in the morning

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Pierre and Marie Curie University: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

Gastroenterology department, Saint Antoine Hospital

Paris, 75571, France

Location

Related Publications (1)

• Sokol H, Landman C, Seksik P, Berard L, Montil M, Nion-Larmurier I, Bourrier A, Le Gall G, Lalande V, De Rougemont A, Kirchgesner J, Daguenel A, Cachanado M, Rousseau A, Drouet E, Rosenzwajg M, Hagege H, Dray X, Klatzman D, Marteau P; Saint-Antoine IBD Network; Beaugerie L, Simon T. Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Microbiome. 2020 Feb 3;8(1):12. doi: 10.1186/s40168-020-0792-5.

  PMID: 32014035 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Harry Sokol, MD, PhD

  Assistance Publique

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 27, 2014
• Study Start: May 1, 2014
• Primary Completion: April 25, 2017
• Study Completion: August 30, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

FR (1)