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Impact of the Fecal Flora Transplantation on Crohn's Disease

NCT02097797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-05

No results posted yet for this study

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

Interventions

OTHER

Fecal Transplantation

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

OTHER

Sham Transplantation

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

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Pierre and Marie Curie University

    collaborator OTHER

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Harry Sokol, MD, PhD · Assistance Publique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-04-25
Completion
2017-08-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097797 on ClinicalTrials.gov