Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Status Terminated

Clinical Trial Summary

Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT).

FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability.

Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm.

At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level.

Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04434872
Study type	Interventional
Source	Tel-Aviv Sourasky Medical Center
Contact
Status	Terminated
Phase	Phase 2
Start date	July 2015
Completion date	July 2016

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