Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)

February 20, 2018 updated by: Weill Medical College of Cornell University
Inflammatory bowel disease is a condition caused by gastrointestinal immune system dysregulation and affected by both genetic and environmental factors. Differences in intestinal bacteria exist between IBD patients and healthy controls, but the role of intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy donor to a patient with altered microbial diversity with the intent of restoring a normal bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively examine the safety of FMT in the management of ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) with significant morbidity and mortality. Current therapies remain limited by side effects and loss of response over time, and there is an ongoing need for new therapies. Fecal microbiota transplantation (FMT), which has proven to be safe and effective in the management of Clostridium difficile infection (CDI) has been proposed as a therapy for UC. There have been studies examining the role of FMT in UC, but they have shown mixed results, and have not examined the underlying immunologic and microbial changes to explain how and why FMT works from specific donors and in certain recipients. Furthermore, no studies have examined the long-term safety of FMT in patients with UC. This proposal aims to examine: (a) the short- and long-term safety of FMT in patients with UC, (b) the efficacy of FMT as a therapy for mild-moderate UC, and (c) the microbial and immunologic changes that occur after FMT, to help understand how and why it works in this group of patients.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with biopsy proven ulcerative colitis (UC), including those with inadequately controlled UC (flare) as defined by failure of standard medical therapy, steroid-dependence, and/or need for escalation of medical care as determined by severity index (Mayo Score), endoscopic or histologic study, and/or medical provider
  • Have active disease, defined with a Mayo Score > 3 and Mayo endoscopic subscore >1
  • Subjects whom the investigator believes can and will comply with the requirements of the protocol
  • Able to provide informed written consent.

Exclusion Criteria:

  • Biopsy-proven Crohn's disease or indeterminate colitis
  • Acute abdomen or other clinical emergencies requiring emergent management (for example: stricture, bowel obstruction, perforation and/or abscess)
  • Primary sclerosing cholangitis (PSC)
  • Pregnancy
  • Concurrent Clostridium difficile infection or other known infection
  • Prior history of fecal microbiota transplantation
  • Other causes of diarrhea, including but not limited to tube feeds and medications (for example, kayaxelate, metformin, lactulose, laxatives, magnesium)
  • Major congenital defects
  • Subjects with recent malignancy in the last 5 years, excluding non-melanoma skin malignancies
  • Anaphylactic reactions to any foods
  • Any antibiotic use within the last 3 months
  • Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplantation
Individuals with Ulcerative Colitis will undergo a fecal microbiota transplantation.
Biological: Fecal Microbiota Transplantation
We will use fecal microbiota transplantation (FMT), with fecal material obtained from OpenBiome or donor directed, to assess safety (as primary outcome) and efficacy (as secondary outcome) in adult (>18 year old) patients with active ulcerative colitis (UC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety post-FMT as determined by interview for adverse events
Time Frame: 36 months post-FMT
Patient information regarding adverse events and safety of FMT for UC will be collected throughout the study period, including day 0, weeks 1, 2, 4, 6, 12 24, and then every 6 months until 36 months post-FMT. Throughout the study period, patients will be assessed for safety with questions regarding general well-being (such as "how have you been feeling?"), as well as specific questions to evaluate for occurrence of adverse events. Patients will also be questioned regarding stool form and frequency, presence of abdominal pain, fevers and subjective well-being.
36 months post-FMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission
Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation
Defined by Mayo score ≤ 2 without any subscore >1, and Mayo endoscopic subscore 0-1
2, 4 and 12 weeks post fecal microbiota transplantation
Clinical Response
Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation
Defined by decrease in Mayo score by 3 points, decrease in bleeding subscore by 1, or absolute subscore of 0-1
2, 4 and 12 weeks post fecal microbiota transplantation
Progression of disease defined by initiation of anti-TNF agents
Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation
Initiation of anti-TNF agents (such as infliximab, adalimumab, certolizumab), vedolizumab, steroids. Includes time gap until additional agents are started
2, 4 and 12 weeks post fecal microbiota transplantation
Progression of disease defined by increase in dosages of current UC medications
Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation
Increase in dosages of current ulcerative colitis specific medications
2, 4 and 12 weeks post fecal microbiota transplantation
Progression of disease defined by time to colectomy
Time Frame: up to three year follow-up period post fecal microbiota transplantation
Time to colectomy rates and increase in time to colectomy
up to three year follow-up period post fecal microbiota transplantation
Death secondary to UC
Time Frame: Anytime during the three year follow-up period post fecal microbiota transplantation
Time to death secondary to ulcerative colitis
Anytime during the three year follow-up period post fecal microbiota transplantation
Progression of disease defined by clinical flare
Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation
Time to next flare
2, 4 and 12 weeks post fecal microbiota transplantation
Microbial changes
Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation
- Alterations in microbial profiles as defined by sequence of genetic material from fecal material.
0, 2 and 4 weeks post fecal microbiota transplantation
Immunological changes
Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation
- Alterations in immune cell function as defined by RNA sequencing and flow cytometry
0, 2 and 4 weeks post fecal microbiota transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Carl V Crawford, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404014982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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