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

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ClinicalTrials.gov Identifier: NCT02390726
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Peter L. Moses, MD, University of Vermont

Brief Summary:

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 or disease Intervention/treatment Phase
Ulcerative Colitis, Active Moderate Biological: Fecal Microbiota Transplant Biological: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Study Start Date : December 2015
Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

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

  3. 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 :
  1. 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:
  1. 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.



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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.

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): NCT02390726


Locations
United States, Vermont
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Peter L Moses, MD The University of Vermont Medical Center

Responsible Party: Peter L. Moses, MD, MD, University of Vermont
ClinicalTrials.gov Identifier: NCT02390726     History of Changes
Other Study ID Numbers: 15373
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

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