Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

NCT ID: NCT04434872

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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:

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.

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

Fecal microbiota transplantation through colonoscopy

Gastroscopy

Intervention Type: PROCEDURE

Fecal microbiota transplantation through gastroscopy

Fecal Microbiota

Intervention Type: DRUG

Enema

Intervention Type: PROCEDURE

Fecal microbiota transplantation through enema

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:

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.

Group Type: PLACEBO_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

Fecal microbiota transplantation through colonoscopy

Gastroscopy

Intervention Type: PROCEDURE

Fecal microbiota transplantation through gastroscopy

Fecal Microbiota

Intervention Type: DRUG

Enema

Intervention Type: PROCEDURE

Fecal microbiota transplantation through enema

Interventions

Colonoscopy

Fecal microbiota transplantation through colonoscopy

Intervention Type: PROCEDURE

Gastroscopy

Fecal microbiota transplantation through gastroscopy

Intervention Type: PROCEDURE

Fecal Microbiota

Intervention Type: DRUG

Enema

Fecal microbiota transplantation through enema

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Gastroentherology

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

0680-14-TLV

Identifier Type: -

Identifier Source: org_study_id