Back to resultsA Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Fecal Microbiota Transplantation
Eligibility Criteria
Inclusion Criteria:
- Men or women, aged 18-65 years old
- Prior endoscopic confirmation of UC:
Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
- Failing standard therapy with:
stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
- Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
- Ability to understand and willingness to sign informed consent document
Exclusion Criteria:
- Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
- Severe or fulminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy
- Patients who have previously undergone FMT
- Patients who have a confirmed malignancy or cancer
- Patients who are immunocompromised
- Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
- Antibiotic use within 2-months of start date
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Probiotic use within 30 days of start date
- Rectal therapy within 14 days of start date
- Decompensated cirrhosis
- Congenital or acquired immunodeficiencies
- Other comorbidities including:
Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
- Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 (40)
- History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
- Steroid >20mg/day
- Positive screening and confirmatory tests for HIV 1 & 2, Hepatitis A, B, & C, and Syphilis
Sites / Locations
- University of Chicago Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fecal microbiota transplantation
Arm Description
Outcomes
Primary Outcome Measures
Comparison of microbiome pre and post transplant
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
Secondary Outcome Measures
Adverse event frequency
Number of patients with reporting adverse events with type and severity of adverse events reported
Tolerance of procedure
Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02058524
Brief Title
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Official Title
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit and enroll eligible subjects.
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Fecal Microbiota Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fecal microbiota transplantation
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
fecal microbiota transplantation
Other Intervention Name(s)
FMT
Primary Outcome Measure Information:
Title
Comparison of microbiome pre and post transplant
Description
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adverse event frequency
Description
Number of patients with reporting adverse events with type and severity of adverse events reported
Time Frame
6 months
Title
Tolerance of procedure
Description
Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
Time Frame
day 0 and day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men or women, aged 18-65 years old
Prior endoscopic confirmation of UC:
Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
Failing standard therapy with:
stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
Ability to understand and willingness to sign informed consent document
Exclusion Criteria:
Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
Severe or fulminate colitis
Women who are pregnant or nursing
Patients who are unable to give informed consent
Patients who are unable or unwilling to undergo colonoscopy
Patients who have previously undergone FMT
Patients who have a confirmed malignancy or cancer
Patients who are immunocompromised
Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
Antibiotic use within 2-months of start date
Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
Probiotic use within 30 days of start date
Rectal therapy within 14 days of start date
Decompensated cirrhosis
Congenital or acquired immunodeficiencies
Other comorbidities including:
Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 (40)
History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
Steroid >20mg/day
Positive screening and confirmatory tests for HIV 1 & 2, Hepatitis A, B, & C, and Syphilis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Kahn, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
We'll reach out to this number within 24 hrs