Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04434872
• Other study ID #: 0680-14-TLV
• Status: Terminated
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Colonoscopy
Fecal microbiota transplantation through colonoscopy
• Gastroscopy
Fecal microbiota transplantation through gastroscopy

Drug:
• Fecal Microbiota

Procedure:
• Enema
Fecal microbiota transplantation through enema

Locations

Country	Name	City	State
Israel	Department of Gastroentherology	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	A composite measure- Will be measured by SCCAI (Simple Clinical Colitis Activity Index) and by MAYO SCORE	8 weeks after FMT
Secondary	Histological remission assessed by sigmoidoscopy	Will be assessed by sigmoidoscopy	8 weeks after FMT
Secondary	Long term remission assessed through questionnaires	Will be assessed through questionnaires	one year after FMT