This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Fecal Microbiota for Transplant, enema product
Fecal Microbiota for Transplant, suspension product
Fecal Microbiota for Transplant, capsule product
Hospital of the Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.
Clinical resolution will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT. Clinical resolution will be defined as follows: * ≤ 4 stools per calendar day for the prior two days with no stool of Bristol stool scale type 7 * No additional stool tests with a positive EIA for C. difficile toxin since study enrollment * No additional prescription or use of anti-CDI antibiotics (unless given for prophylaxis) since study enrollment * No need for an additional
Time frame: 8 weeks
All-cause Mortality at 30-days Following Last FMT
Time frame: 30 days
All-cause Mortality at 60-days Following Last FMT
Time frame: 60 days
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT
Time frame: 30 days
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT
Time frame: 30 days
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT
Time frame: 30 Days
Bacteremia From Enrollment Until 30 Days After Last FMT
Time frame: 30 days
Hospital Admission Within 60 Days of Discharge From Index Hospitalization
Time frame: 60 days
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