This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours: * If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved * Ileus/megacolon either noted as resolved by any provider documentation or not noted * White Blood Cells (WBC) \<15,000 cells/uL * Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 72 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) * Lactate ≤2.2 mmol/L (if measured by clinical care team) * No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) * Temperature \<38.5 °C and ≥35.6°C * \< 8 bowel movements per day and \< 600 mL unformed stool (if volume recorded) * Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria
Time frame: 3 Days
All-cause Mortality at 30 Days Following Last Fecal Microbiota Transplantation (FMT)
Number of deaths within 30 days of the last FMT
Time frame: 30 Days
All-cause Mortality at 60-days Following Last FMT
Number of deaths within 60 days of the 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
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Standard of care antibiotics
Bacteremia From Enrollment Until 30 Days After Last FMT
Time frame: 30 Days
Repeat Hospital Admission Within 60 Days of Discharge From Index Hospitalization
Time frame: 60 Days