Randomized Clinical Trial of Standard FMT Treatments

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Clostridium Difficile

Intervention / Treatment
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* Drug: PRIM-DJ2727


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blinded study for the groups randomized to receive FMT products either from single or three healthy donors
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with RCDI will receive FMT capsules from single donor<br>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) | Drug: PRIM-DJ2727<br>* oral FMT capsules<br>|
| Experimental: Patient will receive FMT capsules from three donors<br>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) | Drug: PRIM-DJ2727<br>* oral FMT capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by number of participants with treatment-related adverse events |  | 60 days |