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

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: NCT02390726
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Peter L. Moses, MD, University of Vermont

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE March 17, 2015
Last Update Posted Date July 9, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02390726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 16, 2015)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Official Title  ICMJE Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis, Active Moderate
Intervention  ICMJE
  • Biological: Fecal Microbiota Transplant
  • Biological: Placebo
Study Arms  ICMJE
  • Sham Comparator: Control
    Sham FMT and Sham Microbial Maintenance plus standard therapy
    Intervention: Biological: Placebo
  • Experimental: Treatment
    FMT and microbial maintenance plus standard therapy
    Intervention: Biological: Fecal Microbiota Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02390726
Other Study ID Numbers  ICMJE 15373
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter L. Moses, MD, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter L Moses, MD The University of Vermont Medical Center
PRS Account University of Vermont
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP