Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04434872
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Procedure: Colonoscopy; Procedure: Gastroscopy; Drug: Fecal Microbiota; Procedure: Enema	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical improvement [8 weeks after FMT]

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

Secondary Outcome Measures

1. Histological remission assessed by sigmoidoscopy [8 weeks after FMT]

   Will be assessed by sigmoidoscopy

2. Long term remission assessed through questionnaires [one year after FMT]

   Will be assessed through questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroentherology	Tel Aviv		Israel	64239

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT04434872
• Other Study ID Numbers: 0680-14-TLV
• First Posted: Jun 17, 2020
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Tel-Aviv Sourasky Medical Center: Microbiota; Ulcerative Colitis
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Jun 17, 2020