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

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ClinicalTrials.gov Identifier: NCT02516384
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: Fecal Microbiota Transplantation Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Progression of disease defined by clinical flare [ Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation ]
    Time to next flare

  8. 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.

  9. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02516384


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Carl V Crawford, MD Weill Medical College of Cornell University

Publications:
Vermeire S JM, Verbeke K, al e. Pilot study on the safety and efficacy of faecal microbiota transplantation in refractory crohn's disease. Gastroenterology 2012, 142:S360.
Angelberger S LC, Gratzer C, al. e. Fecal transplantation in patients with moderately to severely chronic active ulcerative colitis (UC). ECCO Conference Abstracts 2012:P374
Greenberg A AO, Shelton C, Brandt L. Long-term Follow-up Study of Fecal Microbiota Transplantation (FMT) for Inflammatory Bowel Disease (IBD). Am J Gastroenterol 2013, 108:S540.
Brandt L AO, Greenberg A, et al. Safety of Fecal Microbiota Transplantation (FMT) in Immunocompromised (Ic) Patients with Inflammatory Bowel Disease (IBD). Am J Gastroenterol 2013, 108:S556.

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02516384     History of Changes
Other Study ID Numbers: 1404014982
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
Fecal Microbiota Transplantation
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases