Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

NCT04434872 | Terminated Phase 2

• 1 other identifier: 0680-14-TLV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiota; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

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

  8 weeks after FMT

Secondary Outcomes (2)

• Histological remission assessed by sigmoidoscopy

  8 weeks after FMT

• Long term remission assessed through questionnaires

  one year after FMT

Study Arms (2)

FMT from a healthy donor

ACTIVE COMPARATOR

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: 1. 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. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.

Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema

FMT from a self donated stool sample

PLACEBO COMPARATOR

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: 1. 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. 2. Enemas, for patients suffering from colitis that involves the left colon up to 40 cm from the rectum.

Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema

Interventions

Colonoscopy PROCEDURE

Fecal microbiota transplantation through colonoscopy

FMT from a healthy donor; FMT from a self donated stool sample

Gastroscopy PROCEDURE

Fecal microbiota transplantation through gastroscopy

FMT from a healthy donor; FMT from a self donated stool sample

Fecal Microbiota DRUG

FMT from a healthy donor; FMT from a self donated stool sample

Enema PROCEDURE

Fecal microbiota transplantation through enema

FMT from a healthy donor; FMT from a self donated stool sample

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 3 month diagnosis of ulcerative colitis
• Active Colitis disease with endoscopic score \>0
• Ability to sign an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Gastroentherology

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Colonoscopy; Gastroscopy; Fecal Microbiota Transplantation; Enema

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Biological Therapy; Therapeutics; Drug Therapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 17, 2020
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

IL (1)