- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04729790
Randomized Clinical Trial of Standard FMT Treatments (FMT)
January 25, 2021 updated by: Herbert DuPont, MD, The University of Texas Health Science Center, Houston
Phase II Randomized Clinical Trial of Standard FMT Treatments: Non-powered Pilot Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (RCDI) Using Either Single or Three Combined Products From Healthy Donors
This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI).
Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days).
All subjects will be followed for approximately 180 days following FMT treatment for safety.
Study Overview
Detailed Description
The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.
Study Type
Interventional
Phase
- Phase 2
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects 18 years of age or older.
- Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
- Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
- Subject/LAR willing and able to provide informed consent.
- Able to follow study procedures and complete the follow-up questionnaire for safety.
- Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
- Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
- Received at least two courses of standard-of-care antibiotic therapy for CDI.
Exclusion Criteria:
- Unable to take capsules orally.
- Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
- Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
- Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
- Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
- Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
- Life expectancy of < 6 months.
- In the opinion of investigator, subject for any reason, should be excluded from the study.
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: Patients with RCDI will receive FMT capsules from single donor
Capsules made with intestinal bacteria from single healthy donor
|
oral FMT capsules
|
Experimental: Patient will receive FMT capsules from three donors
Capsules made of intestinal bacteria from three healthy donors
|
oral FMT capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as assessed by number of participants with treatment-related adverse events
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Herbert l DuPont, MD, University of Texas Health Science Center School of Public Health
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 (Anticipated)
January 10, 2020
Primary Completion (Anticipated)
January 30, 2022
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
January 20, 2021
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-19-0950
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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