Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Phase 2TerminatedNCT04434872

Tel-Aviv Sourasky Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Over 3 month diagnosis of ulcerative colitis * Active Colitis disease with endoscopic score \>0 * Ability to sign an informed consent Exclusion Criteria: * Acute neutrophilia (under 500 neutrophils) * Clostridium difficile infection * Exposure to antibiotics 2 weeks prior to enrollment. * Severe immune deficiency * Hospitalization * Proctitis involving less than 10cm of the rectum * Malignancy with the past 5 years (excluding BCC) * An unstable dose of steroids or 5ASA (5- aminosalicylic acid) with the past 2 weeks or of immunomodulators or biologic therapy within the past 12 weeks

Outcomes

Primary Outcomes

Clinical improvement

A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE

Time frame: 8 weeks after FMT

Secondary Outcomes

Histological remission assessed by sigmoidoscopy

Will be assessed by sigmoidoscopy

Time frame: 8 weeks after FMT

Long term remission assessed through questionnaires

Will be assessed through questionnaires

Time frame: one year after FMT