Trials / Active Not Recruiting
Active Not RecruitingNCT05632315
PMT for MDRO Decolonization
A Phase II Randomized Trial to Evaluate the Impact of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products on Recipient and Environmental Colonization With Multidrug-Resistant Organisms
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (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 trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant bacteria.
Conditions
- Multidrug Resistant Bacterial Infection
- Enterobacteriaceae Infections
- Pseudomonas Aeruginosa
- VRE Infection
- Methicillin-resistant Staphylococcus Aureus
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PMT | Fecal Microbiota for Transplant, enema product (PMT-001) or Fecal Microbiota for Transplant, suspension product (PMT-002) |
Timeline
- Start date
- 2024-08-19
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2022-11-30
- Last updated
- 2026-04-13
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05632315. Inclusion in this directory is not an endorsement.