Clinical trial NCT03298048: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent C. Difficile Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as Assessed by Number of Participants With Nausea
timeFrame: 180 days
measure: Safety as Assessed by Number of Participants With Vomiting
timeFrame: 180 days
measure: Safety as Assessed by Number of Participants With Diarrhea
timeFrame: 180 days
measure: Safety as Assessed by Number of Participants With Bloating
timeFrame: 180 days
measure: Safety as Assessed by Number of Participants With Constipation
timeFrame: 180 days
Secondary outcomes:
measure: Number of Participants With Recurrent C. Difficile Infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth School of Public Health
name: Herbert L DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References: