Back to resultsRandomized Clinical Trial of Standard FMT Treatments (FMT)
Primary Purpose
Clostridium Difficile
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PRIM-DJ2727
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Patients with RCDI will receive FMT capsules from single donor
Patient will receive FMT capsules from three donors
Arm Description
Capsules made with intestinal bacteria from single healthy donor st treatment day, lyophilized product generated from single donor (90g of stool) nd treatment day, lyophilized product generated from single donor (90g of stool)
Capsules made of intestinal bacteria from three healthy donors st treatment day, lyophilized product generated from three donors (90g of stool) nd treatment day, lyophilized product generated from three donors (90g of stool)
Outcomes
Primary Outcome Measures
Safety as assessed by number of participants with treatment-related adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT04729790
First Posted
January 20, 2021
Last Updated
January 25, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04729790
Brief Title
Randomized Clinical Trial of Standard FMT Treatments
Acronym
FMT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No Funding
Study Start Date
January 10, 2020 (Anticipated)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blinded study for the groups randomized to receive FMT products either from single or three healthy donors
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
An independent statistician will develop a randomization list using SAS. Randomization in permuted blocks will be used to achieve balance across treatment groups. The randomization scheme consists of a sequence of blocks such that each block contains a pre-specified number of treatment assignments in random order. The purpose of this is to balance the randomization scheme at the completion of each block. The target sample size is 200 evaluable subjects or as many as can be done up to that number.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with RCDI will receive FMT capsules from single donor
Arm Type
Active Comparator
Arm Description
Capsules made with intestinal bacteria from single healthy donor
st treatment day, lyophilized product generated from single donor (90g of stool)
nd treatment day, lyophilized product generated from single donor (90g of stool)
Arm Title
Patient will receive FMT capsules from three donors
Arm Type
Experimental
Arm Description
Capsules made of intestinal bacteria from three healthy donors
st treatment day, lyophilized product generated from three donors (90g of stool)
nd treatment day, lyophilized product generated from three donors (90g of stool)
Intervention Type
Drug
Intervention Name(s)
PRIM-DJ2727
Intervention Description
oral FMT capsules
Primary Outcome Measure Information:
Title
Safety as assessed by number of participants with treatment-related adverse events
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert l DuPont, MD
Organizational Affiliation
University of Texas Health Science Center School of Public Health
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Clinical Trial of Standard FMT Treatments
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