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Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434872
Recruitment Status : Terminated (Lack of budget)
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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

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

Resource links provided by the National Library of Medicine


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:

  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
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:

  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
Fecal microbiota transplantation through colonoscopy

Procedure: Gastroscopy
Fecal microbiota transplantation through gastroscopy

Drug: Fecal Microbiota
Procedure: Enema
Fecal microbiota transplantation through enema




Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 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 [ Time Frame: 8 weeks after FMT ]
    Will be assessed by sigmoidoscopy

  2. Long term remission assessed through questionnaires [ Time Frame: one year after FMT ]
    Will be assessed through questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434872


Locations
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Israel
Department of Gastroentherology
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04434872    
Other Study ID Numbers: 0680-14-TLV
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Tel-Aviv Sourasky Medical Center:
Microbiota
Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases