Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Recurrent Clostridium Difficile Infection Clinical Trial

Official title:

A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03973697
• Other study ID #: IRB # 832963
• Status: Terminated
• Phase: Phase 2
• Start date: January 13, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 31, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence
• Recurrent Clostridium Difficile Infection

Intervention

Drug:
• Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
• Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
• Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product

Locations

Country	Name	City	State
United States	Hospital of the Univeristy of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control.	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	8 weeks
Secondary	All-cause Mortality at 30-days Following Last FMT		30 days
Secondary	All-cause Mortality at 60-days Following Last FMT		60 days
Secondary	Colectomy or Diverting Ileostomy Within 30 Days After Last FMT		30 days
Secondary	Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT		30 days
Secondary	Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT		30 Days
Secondary	Bacteremia From Enrollment Until 30 Days After Last FMT		30 days
Secondary	Hospital Admission Within 60 Days of Discharge From Index Hospitalization		60 days