Phage Therapy for MDRO Decolonization
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you must be on appropriate antibiotic treatment for the qualifying MDRO infection to participate.
What data supports the idea that Phage Therapy for MDRO Decolonization is an effective treatment?
The available research shows that Phage Therapy for MDRO Decolonization, also known as Fecal Microbiota Transplant (FMT), is effective in treating infections caused by multidrug-resistant organisms. For example, one study documented that FMT successfully decolonized carbapenem-resistant Enterobacteriaceae, including harmful bacteria like Klebsiella and E. coli, in patients. This was achieved by introducing beneficial bacteria and viruses from a healthy donor, which helped reduce the harmful bacteria. Additionally, FMT has been highly effective in treating Clostridium difficile infections, with success rates nearing 100%, and is being explored for other conditions like inflammatory bowel disease and colon cancer. This suggests that FMT can be a powerful tool in managing various gut-related health issues.12345
What safety data exists for phage therapy in MDRO decolonization?
The safety data for phage therapy, particularly under the guise of fecal microbiota transplantation (FMT), indicates that it is a safe and effective treatment for Clostridium difficile infection (CDI). FMT has been widely accepted for CDI due to its high success rates and is considered safe for this condition. However, its use outside of CDI, such as for inflammatory bowel disease, ulcerative colitis, and other gastrointestinal conditions, is still under research, with safety and efficacy not fully established. The transfer of bacteriophages during FMT has been documented, but the clinical significance and safety implications of this are not yet clear. Therefore, while FMT shows promise, more research is needed to fully understand its safety profile in conditions beyond CDI.34678
Is PMT a promising treatment for MDRO decolonization?
Yes, PMT, which includes Fecal Microbiota Transplant (FMT), is a promising treatment because it has been effective in treating various conditions related to the gut microbiome. It has shown high success rates in treating infections like Clostridioides difficile and is being explored for other uses, including reducing antibiotic use and hospital stays in patients with multidrug-resistant organisms.4791011
Research Team
Brendan J Kelly
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for adults over 18 with certain drug-resistant infections (like MRSA, VRE, or resistant Pseudomonas) who are on specific antibiotics. They must have a few days left of treatment and not be allergic to fecal microbiota transplant products. Pregnant women can't join, and participants must use birth control if they can have children.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fecal microbiota transplant using Penn Microbiome Therapy (PMT) products alongside standard therapy to eradicate antibiotic-resistant bacteria
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PMT
PMT is already approved in United States for the following indications:
- Decolonization of antibiotic-resistant bacteria
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor