Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

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.

Timeline

Start

2015-07

Primary completion

2016-07

Completion

2016-07

Drugs

Indications