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)

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Recurrent C. Difficile Infection

Treatments: Biological: Low fecal microbiota dose; Biological: Mid fecal microbiota dose; Biological: High fecal microbiota dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03298048

HSC-SPH-17-0614

Details and patient eligibility

About

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

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 3 patient groups

Low fecal microbiota dose

Active Comparator group

Description:

receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days

Treatment:

Biological: Low fecal microbiota dose

Mid fecal microbiota dose

Active Comparator group

Description:

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

Treatment:

Biological: Mid fecal microbiota dose

High fecal microbiota dose

Active Comparator group

Description:

receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days

Treatment:

Biological: High fecal microbiota dose