MedTrace Logo

Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

NCT04434872 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-17

No results posted yet for this study

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

Interventions

PROCEDURE

Colonoscopy

Fecal microbiota transplantation through colonoscopy

PROCEDURE

Gastroscopy

Fecal microbiota transplantation through gastroscopy

DRUG

Fecal Microbiota

PROCEDURE

Enema

Fecal microbiota transplantation through enema

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Israel

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 NCT04434872 on ClinicalTrials.gov