- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03948919
Low Sulfur Fecal Transplant for Ulcerative Colitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inflammatory bowel disease (IBD) is a chronic, relapsing remitting inflammatory disease of the intestine. The two main forms of IBD are Crohn's disease (CD) and Ulcerative Colitis (UC). There is no cure for IBD and the etiology is unknown, however IBD is thought to arise as an aberrant immune response to the intestinal microbiota. The intestinal microbiota closely correlates with inflammation in IBD. Currently, the treatment of IBD is based on suppressing the aberrant immune response in the intestine. This often takes the form of systemic immunosuppression, which in turn carries a multitude of risks including infection and malignancy. Thus there is an urgent need for safe, effective therapies that ultimately have the potential to cure IBD.
Fecal microbiota transplantation (FMT) is the process of transferring fecal microbiota from one individual to another. FMT has revolutionized the treatment of multiple recurrent Clostridium difficile infection with a cure rate around 90%. Given the success of FMT in C. difficile colitis, attention turned to other forms of colitis, in particular IBD. Early pilot studies demonstrated a mixed result for the use of FMT in IBD. One of the key issues surrounding the use of FMT in IBD is the challenge of engrafting a new microbiota. Additionally IBD flares following FMT for C. difficile infection have been reported, although it is difficult to account for the confounding of the underlying C. difficile infection. This study will examine how FMT donor selection can impact the engraftment of the microbiota into patients with UC.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able and willing to provide consent
- English speaking
- Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis
- Diagnosis of ulcerative colitis > 3 months
- Active disease on endoscopy (endoscopic Mayo subscore ≥ 1)
- Evidence of inflammation extending beyond a minimum of 20cm
- Any ongoing ulcerative colitis therapy must be at stable doses for 4 weeks prior to study and remain stable over the course of the study
Exclusion Criteria:
- Extensive bowel resection
- Presence of ileostomy or colostomy
- Suspicion of ischemic colitis, radiation colitis or microscopic colitis
- Diagnosis of Crohn's disease
- Diagnosis of per-anal fistula or abscess
- Adenomatous polyps that have not been removed
- Use of pre or probiotics within 30 days of randomization
- Pregnancy
- Severe food allergies
- End stage liver disease or cirrhosis
- An absolute neutrophil count < 500 cell/µL
- Life expectancy < 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FMT Treatment
Fecal microbiota - 1.0-3.0
x 10^11 CFU / day (2 capsules per day for 8 weeks).
|
Lyophilized encapsulated fecal microbiota given daily for 8 weeks.
|
Placebo Comparator: Placebo
The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.
Two capsules taken daily for 8 weeks.
|
Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment of low sulfate reducing microbiota
Time Frame: 12 weeks
|
Change in quantitative PCR of sulfate reducing genes from baseline to week 12 between FMT arm and placebo arm.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change of sulfate reducing microbiota
Time Frame: 4 weeks
|
Change in quantitative PCR of sulfate reducing genes at week 1, 2, 3 and 4 between FMT arm and placebo arm
|
4 weeks
|
Clinical efficacy of FMT versus placebo
Time Frame: 8 weeks
|
Change in partial Mayo score from baseline to week 8 between FMT and placebo arm
|
8 weeks
|
Clinical efficacy of low sulfate reducing microbiota
Time Frame: 12 weeks
|
Partial mayo score at week 12 between those with low sulfate reducing microbiota or not low sulfate reducing microbiota
|
12 weeks
|
Serious adverse events
Time Frame: 12 weeks
|
Number of serious adverse events between FMT arm and placebo arm
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Byron Vaughn, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GI-2019-27285
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Fecal microbiota
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The University of Texas Health Science Center,...TerminatedRecurrent C. Difficile InfectionUnited States
-
The Second Hospital of Nanjing Medical UniversityRecruiting
-
Madhusudan (Madhu) Grover, MBBSRecruiting
-
Medical University of GrazBristol-Myers SquibbTerminatedMalignant Melanoma Stage III | Malignant Melanoma Stage IV | Fecal Microbiota TransplantationAustria
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Chinese University of Hong KongActive, not recruitingIrritable Bowel Syndrome | Fecal Microbiota TransplantationHong Kong
-
University Hospital, GhentResearch Foundation FlandersRecruitingResistance BacterialBelgium
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The First Affiliated Hospital of Nanchang UniversityCompletedAcute Pancreatitis | Intestinal Bacteria Flora Disturbance | Fecal Microbiota Transplantation | Intestinal DysfunctionChina
-
Jinling Hospital, ChinaUnknown
-
The First Affiliated Hospital of Soochow UniversityRecruiting
-
Duke UniversityRecruitingClostridium Difficile ColitisUnited States