Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

University of Pennsylvania

Status and phase: Terminated; Phase 2

Conditions: Recurrent Clostridium Difficile Infection

Treatments: Drug: Penn Microbiome Therapy - 003; Drug: Penn Microbiome Therapy - 002; Drug: Penn Microbiome Therapy - 001

Study type: Interventional

Funder types: Other

Identifiers

NCT03973697

IRB # 832963

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Single dose of PMT

Experimental group

Treatment:

Drug: Penn Microbiome Therapy - 001

Drug: Penn Microbiome Therapy - 002

Drug: Penn Microbiome Therapy - 003

Two doses of PMT

Experimental group

Description:

Administered within 24 hours

Treatment:

Drug: Penn Microbiome Therapy - 001

Drug: Penn Microbiome Therapy - 002

Drug: Penn Microbiome Therapy - 003