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Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

NCT03973697 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-11-01

Study results available
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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).

Conditions

  • Recurrent 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

Sponsors & Collaborators

Principal Investigators

  • Ebbing Lautenbach, MD, MPH, MSCE · 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
2020-01-13
Primary Completion
2021-08-11
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03973697 on ClinicalTrials.gov