Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Tel Aviv Sourasky Medical Center

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04434872

0680-14-TLV

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

FMT from a healthy donor

Active Comparator group

Description:

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.

Treatment:

Procedure: Colonoscopy

Procedure: Enema

Drug: Fecal Microbiota

Procedure: Gastroscopy

FMT from a self donated stool sample

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Colonoscopy

Procedure: Enema

Drug: Fecal Microbiota

Procedure: Gastroscopy