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Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)

NCT03970200 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-30

Study results available
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Summary

This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).

Conditions

  • Severe Clostridium Difficile Infection
  • Severe-Complicated/Fulminant Clostridium Difficile Infection

Interventions

DRUG

Penn Microbiome Therapy - 001

Fecal Microbiota for Transplant, enema product

DRUG

Penn Microbiome Therapy - 002

Fecal Microbiota for Transplant, suspension product

DRUG

Penn Microbiome Therapy - 003

Fecal Microbiota for Transplant, capsule product

DRUG

Antibiotics

Standard of care antibiotics

Sponsors & Collaborators

Principal Investigators

  • Ebbing Lautenbach, MD, MPH, MSCE · Division of Infectious Diseases, Department of Medicine, University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-11-21
Completion
2022-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970200 on ClinicalTrials.gov