Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Condition: Recurrent Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: Penn Microbiome Therapy - 001; Penn Microbiome Therapy - 002; Penn Microbiome Therapy - 003
Intervention description: Fecal Microbiota for Transplant, enema product; Fecal Microbiota for Transplant, suspension product; Fecal Microbiota for Transplant, capsule product
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open label, comparative
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.