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Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis (FMTUC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Peter L. Moses, MD, University of Vermont
ClinicalTrials.gov Identifier:
NCT02390726
First received: February 19, 2015
Last updated: March 22, 2017
Last verified: March 2017
  Purpose

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment.

The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.


Condition Intervention Phase
Ulcerative Colitis, Active Moderate
Biological: Fecal Microbiota Transplant
Biological: Placebo
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Asses Endoscopic Stages of the Colon Pre/Post FMT [ Time Frame: 2 years ]
    Assess endoscopic stage of the inflamed colon (endoscopic Mayo score) and assess the histologic stage of the biopsied colon (quiescent/mild/moderate/severe) pre and post FMT.

  • Asses Biologic Inflammatory Markers [ Time Frame: 2 years ]
    Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.

  • Review and Track Patient reported Outcomes via Validated Questionnaires [ Time Frame: 2 Years ]
    Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)


Secondary Outcome Measures:
  • Change in metagenomic sequencing in Stool samples after FMT treatment [ Time Frame: After 6, 12, and 18 Weeks ]
    Trace the effect FMT therapy has on microbiome diversity and to track whether this effect is sustained during and after therapy via metagenomic sequencing of stool samples at time 0, and weeks 6, 12, and 18.


Other Outcome Measures:
  • Asses changes in T-cell measures and serotonin signaling in mucosal biopsy samples and peripheral blood samples [ Time Frame: 2 years ]
    Explore potential therapeutic mechanisms of FMT therapy. Changes in the host immune response before and after treatment will be assessed via measurement of both mucosal and peripheral T-cells populations (Th1, Th2, Th17) using mucosal biopsies and blood samples respectively.Changes in mucosal serotonin signaling will be measured using mucosal biopsies.


Estimated Enrollment: 20
Study Start Date: December 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Sham FMT and Sham Microbial Maintenance plus standard therapy
Biological: Placebo
Experimental: Treatment
FMT and microbial maintenance plus standard therapy
Biological: Fecal Microbiota Transplant

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women 18-75 years of age.
  • Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
  • Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
  • Patients may be on any class of IBD-related medication (excluding steroids)
  • Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
  • Ability to understand and willingness to sign informed consent document

Exclusion Criteria:

  • Patient who are asymptomatic
  • Patients with severe, refractory disease (defined as Mayo scores of > 10, or endoscopic disease activity score of > 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
  • Prior colectomy
  • Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
  • Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
  • Systemic antibiotic use within prior 6 weeks to enrollment
  • Regular probiotic supplement use within prior 48 hours to enrollment
  • Pregnancy or breastfeeding
  • Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
  • History of anaphylaxis (severe allergic reaction)
  • Documented allergy to fluoroquinolones, metronidazole
  • Life expectancy less than 12 months
  • Age less than 18 or greater than 75 years of age
  • History of esophageal or gastric motility disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02390726

Contacts
Contact: Peter L Moses, MD 802-847-2554 peter.moses@uvmhealth.org
Contact: Magen N Phillips, BS 802-656-9094 magen.phillips@med.uvm.edu

Locations
United States, Vermont
The University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Magen N Phillips, BS    802-656-9094    magen.phillips@med.uvm.edu   
Principal Investigator: Peter L Moses, MD         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Peter L Moses, MD The University of Vermont Medical Center
  More Information

Responsible Party: Peter L. Moses, MD, MD, University of Vermont
ClinicalTrials.gov Identifier: NCT02390726     History of Changes
Other Study ID Numbers: 15373
Study First Received: February 19, 2015
Last Updated: March 22, 2017

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

ClinicalTrials.gov processed this record on March 28, 2017