NCT04434872

Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
PROCEDURE	Colonoscopy	Fecal microbiota transplantation through colonoscopy
PROCEDURE	Gastroscopy	Fecal microbiota transplantation through gastroscopy
DRUG	Fecal Microbiota
PROCEDURE	Enema	Fecal microbiota transplantation through enema

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2020-06-17
• Last updated: 2020-06-17

Locations

1 site across 1 country: Israel