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)

Study Overview
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Brief Summary
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To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

Detailed Description
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This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.

Official Title
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Phase II. 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)

Conditions
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Recurrent C. Difficile Infection

Intervention / Treatment
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* Biological: Low fecal microbiota dose
* Biological: Mid fecal microbiota dose
* Biological: High fecal microbiota dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period 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: Unable to take capsules orally 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low fecal microbiota dose<br>receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days | Biological: Low fecal microbiota dose<br>* receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days<br>* Other names: Fecal microbiota transplantation (FMT);|
| Active Comparator: Mid fecal microbiota dose<br>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 | Biological: Mid fecal microbiota dose<br>* 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<br>* Other names: Fecal microbiota transplantation (FMT);|
| Active Comparator: High fecal microbiota dose<br>receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days | Biological: High fecal microbiota dose<br>* receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days<br>* Other names: Fecal microbiota transplantation (FMT);|

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 Nausea |  | 180 days | 
| Safety as Assessed by Number of Participants With Vomiting |  | 180 days | 
| Safety as Assessed by Number of Participants With Diarrhea |  | 180 days | 
| Safety as Assessed by Number of Participants With Bloating |  | 180 days | 
| Safety as Assessed by Number of Participants With Constipation |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Recurrent C. Difficile Infection |  | 6 months |