Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
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).
Inclusion Criteria:

 1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with
 symptoms including bowel movement altered in frequency or consistency from baseline.

 2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of
 enrollment.

 3. At least one additional prior positive stool test for C. difficile within the prior 12
 months (EIA or NAAT as above).

 4. Age ≥ 18 years.

 5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin)
 antibiotic treatment for R-CDI prior to intervention.

 Exclusion Criteria:

 1. Evidence of colon/small bowel perforation at the time of study screening

 2. Goals of care are directed to comfort rather than curative measures.

 3. Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.

 4. Known food allergy that could lead to anaphylaxis.

 5. Pregnancy

 a. For subjects of childbearing potential (ages 18 to 55), the subject must have a
 negative urine pregnancy test within 48 hours of consent and no more than 48 hours
 prior to first product administration

 6. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of
 planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any
 one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2)
 hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or
 requiring pressors; (3) provider documentation of ileus or radiologic evidence of
 bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum
 creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L;
 or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include
 heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 <
 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10%
 immature (band) forms).

 7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.