Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Phase 2

Terminated

• Conditions: Recurrent Clostridium Difficile Infection
• Interventions: Drug: Penn Microbiome Therapy - 001; Drug: Penn Microbiome Therapy - 002; Drug: Penn Microbiome Therapy - 003

• Registration Number: NCT03973697
• Lead Sponsor: University of Pennsylvania

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Study Start: 2020-01-13
• Primary Completion: 2021-08-11
• Study Completion: 2021-12-31
• Disposition First Submitted: 2022-06-16
• Disposition First Submitted QC: 2022-06-16
• Disposition First Posted: 2022-06-21
• Status Verified: 2023-10
• Results First Submitted: 2023-10-06
• Results First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Results First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose of PMT	Penn Microbiome Therapy - 001	-
Single dose of PMT	Penn Microbiome Therapy - 002	-
Single dose of PMT	Penn Microbiome Therapy - 003	-
Two doses of PMT	Penn Microbiome Therapy - 002	Administered within 24 hours
Two doses of PMT	Penn Microbiome Therapy - 003	Administered within 24 hours
Two doses of PMT	Penn Microbiome Therapy - 001	Administered within 24 hours

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.	8 weeks	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

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality at 60-days Following Last FMT	60 days
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT	30 Days
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT	30 days
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT	30 days
Bacteremia From Enrollment Until 30 Days After Last FMT	30 days
Hospital Admission Within 60 Days of Discharge From Index Hospitalization	60 days
All-cause Mortality at 30-days Following Last FMT	30 days

Trial Locations

Locations (1)

Hospital of the Univeristy of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States