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

Primary Purpose

Ulcerative Colitis, Active Moderate

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Placebo
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis, Active Moderate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Vermont Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Sham FMT and Sham Microbial Maintenance plus standard therapy

FMT and microbial maintenance plus standard therapy

Outcomes

Primary Outcome Measures

Asses Endoscopic Stages of the Colon Pre/Post FMT
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
Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.
Review and Track Patient reported Outcomes via Validated Questionnaires
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
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.

Full Information

First Posted
February 19, 2015
Last Updated
July 6, 2018
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT02390726
Brief Title
Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Acronym
FMTUC
Official Title
Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Active Moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham FMT and Sham Microbial Maintenance plus standard therapy
Arm Title
Treatment
Arm Type
Experimental
Arm Description
FMT and microbial maintenance plus standard therapy
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Asses Endoscopic Stages of the Colon Pre/Post FMT
Description
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.
Time Frame
2 years
Title
Asses Biologic Inflammatory Markers
Description
Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.
Time Frame
2 years
Title
Review and Track Patient reported Outcomes via Validated Questionnaires
Description
Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Change in metagenomic sequencing in Stool samples after FMT treatment
Description
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.
Time Frame
After 6, 12, and 18 Weeks
Other Pre-specified Outcome Measures:
Title
Asses changes in T-cell measures and serotonin signaling in mucosal biopsy samples and peripheral blood samples
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L Moses, MD
Organizational Affiliation
The University of Vermont Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34238227
Citation
Crothers JW, Chu ND, Nguyen LTT, Phillips M, Collins C, Fortner K, Del Rio-Guerra R, Lavoie B, Callas P, Velez M, Cohn A, Elliott RJ, Wong WF, Vo E, Wilcox R, Smith M, Kassam Z, Budd R, Alm EJ, Mawe GM, Moses PL. Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. BMC Gastroenterol. 2021 Jul 8;21(1):281. doi: 10.1186/s12876-021-01856-9.
Results Reference
derived

Learn more about this trial

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

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