Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

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 Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Department of Gastroentherology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FMT from a healthy donor; Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.; Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.	Procedure: Colonoscopy; Fecal microbiota transplantation through colonoscopy; Procedure: Gastroscopy; Fecal microbiota transplantation through gastroscopy; Drug: Fecal Microbiota; Procedure: Enema; Fecal microbiota transplantation through enema
Placebo Comparator: FMT from a self donated stool sample; Patients will undergo FMT 4 times during the study: first time, through a colonoscopy (sample volume: 250ml), and 3 more times (each sample volume: 100ml) during the following three days through: A Naso-jejunal feeding tube (that will be inserted through a gastroscopy) for patients suffering from colitis that involves more than 40 cm of the colon.; Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.	Procedure: Colonoscopy; Fecal microbiota transplantation through colonoscopy; Procedure: Gastroscopy; Fecal microbiota transplantation through gastroscopy; Drug: Fecal Microbiota; Procedure: Enema; Fecal microbiota transplantation through enema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE	8 weeks after FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological remission assessed by sigmoidoscopy	Will be assessed by sigmoidoscopy	8 weeks after FMT
Long term remission assessed through questionnaires	Will be assessed through questionnaires	one year after FMT

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Microbiota; Ulcerative Colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 0680-14-TLV