- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617445
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
August 2, 2023 updated by: University of Wisconsin, Madison
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Clostridium difficile (C.difficile) is a pathogen of major public health importance, especially in individuals with comorbid conditions such as solid organ transplantation (SOT).
The incidence and adverse outcomes of CDI are greatly amplified in the setting of SOT, due to healthcare exposure, antibiotic use and immunosuppression, all of which are ubiquitous in SOT recipients.
There are currently no effective treatment options to achieve a sustained cure of recurrent CDI and prevent further recurrence in SOT recipients.
A novel approach that has recently gained attention is restoration of the CDI impaired gut microbiome by instillation of stool from a healthy donor into the intestine of a CDI patient.
This treatment, called Fecal Microbiota Transplantation (FMT) has been found in non-comparative studies to reduce CDI recurrence dramatically with a reported efficacy of over 95%, however its efficacy in SOT recipients has not been studied and cannot be extrapolated from results in the non-SOT population because SOT recipients are a unique study population due to profound immunosuppression, frequent antibiotic use and frequent opportunities for exposure to CDI all of which markedly, repeatedly and persistently disrupt the gut microbiome.
Thus, this critical gap in the field needs to be addressed by a trial of FMT in SOT recipients with CDI.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph Perzynski, MSW
- Phone Number: 608-263-7825
- Email: jdperzyn@medicine.wisc.edu
Study Contact Backup
- Name: Shelly Zimbric, BS
- Phone Number: 608-265-8799
- Email: mlzimbri@wisc.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital & Clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Is willing to provide written informed consent.
- Is willing to comply with all study procedures and be available for the duration of the study.
- Can take oral medication
- At least 18 years of age.
- Is a solid organ transplant (SOT) recipient
- Has had at recurrent C. difficile infection defined as: positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 180 day period following completion of treatment for prior episode
- History of positive IgG test to cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) for subject or donor
- Clinical response to 4-14 days of oral antibiotic standard of care treatment for the current episode of CDI. Clinical response is defined as greater than or equal to 25% reduction of diarrhea.
- Negative urine or serum pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment
Exclusion Criteria:
- Major bowel resection surgery within 90 days of randomization
- Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
- History of total colectomy or bariatric surgery
- Known or suspected toxic megacolon and/or small bowel ileus
- Presence of colostomy or ileostomy.
- Taking concomitant antibiotics within 48 hours of Visit 2. Topical antibiotics, and antibiotics for transplant prophylaxis are permitted
- Dysphagia; oropharyngeal, S), or patient has evidence of dysphagia when the 'safety test' capsule is administered
- Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT
- Active, Severe Gastroparesis
- Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are not prohibited
- Neutropenia, ≤ 500 neutrophils/ml [noted in medical records and resulted within 7 days of Visit 1])
- Symptomatic co-infection with another intestinal pathogen as determined by chart review
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for any active malignancy. Patients on maintenance chemotherapy could be enrolled after consultation with the study Medical Monitor
- Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions
- Expected life expectancy is less than 6 months
- Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
- Women who are pregnant, lactating or planning on becoming pregnant during the study
- Not suitable for study participation due to other reasons at the discretion of the investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FMT oral capsules/ oral vancomycin placebo
FMT plus placebo vancomycin
|
FMT oral capsules, single dose of 5 capsules
Other Names:
Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.
Other Names:
|
Active Comparator: Placebo FMT capsules/ Active oral vancomycin
Vancomycin plus FMT enema placebo
|
Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days
Other Names:
Placebo oral capsules, single dose of 5 capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the rate of recurrence of CDI in solid organ transplant recipients with FMT compared with oral vancomycin
Time Frame: 2 consecutive days
|
Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period)
|
2 consecutive days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CDI-related QOL
Time Frame: At baseline, week 4 and at 29 weeks
|
Cdiff 32
|
At baseline, week 4 and at 29 weeks
|
Compare the change in gut microbiota and evaluate the association between the change in gut microbiota and recurrence of CDI
Time Frame: up to 30 weeks of study participation
|
Using multiple metric of microbiota structure and function
|
up to 30 weeks of study participation
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Evaluate the short- and medium-term safety of FMT in SOT patients
Time Frame: Up 30 weeks of study participation
|
Closely follow safety events
|
Up 30 weeks of study participation
|
Compare the effects of FMT and oral vancomycin on intestinal colonization by multi-drug-resistant organisms other than C. difficile in SOT patients
Time Frame: up to 30 weeks of study participation
|
Analysis of stool samples
|
up to 30 weeks of study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nasia Safdar, MD, PhD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
July 27, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
August 4, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1056
- A534265 (Other Identifier: UW, Madison)
- SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison)
- Protocol Version 8/24/2022 (Other Identifier: UW Madison)
- 1U01AI125053-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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