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)

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)

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

Study Overview

• Status: Terminated
• Conditions: Recurrent C. Difficile Infection
• Intervention / Treatment: Biological: Low fecal microbiota dose; Biological: Mid fecal microbiota dose; Biological: High fecal microbiota dose

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Herbert L DuPont, MD, UTHealth School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: HSC-SPH-17-0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No