Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
NCT ID: NCT03298048
Last Updated: 2020-03-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
17 participants
INTERVENTIONAL
2017-12-21
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Interventions
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Low fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
Mid fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
High fecal microbiota dose
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
* Subject willing to sign an informed consent form
* Subject deemed likely to survive for ≥ 1 year after enrollment
* Able to follow study procedure and follow-ups
* Subjects' attending physician will provide non-transplant care for the subject
* Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
* Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
* Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight
Exclusion Criteria
* Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
* Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
* Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
* Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
18 Years
100 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Herbert DuPont
Professor of Medicine
Principal Investigators
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Herbert L DuPont, MD
Role: PRINCIPAL_INVESTIGATOR
UTHealth School of Public Health
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-SPH-17-0614
Identifier Type: -
Identifier Source: org_study_id
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