NCT03973697

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-01-13
• Primary completion: 2021-08-11
• Completion: 2021-12-31
• First posted: 2019-06-04
• Last updated: 2023-11-01
• Results posted: 2023-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study