Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
Status:
Terminated
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.