Fecal Microbiota Transplant for Clostridium Infections
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on prolonged antibiotic treatment that affects the gut. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Autologous Fecal Microbiota Transplantation (Auto-FMT) for Clostridium infections?
Is fecal microbiota transplantation (FMT) safe for humans?
How is Autologous Fecal Microbiota Transplantation (Auto-FMT) different from other treatments for Clostridium infections?
What is the purpose of this trial?
The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.
Research Team
Ying Taur, MD, MPH
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for adults (18+) who are scheduled to receive an allogeneic hematopoietic stem cell transplantation (allo-HSCT). It's not suitable for those with severe colitis, a history of inflammatory bowel disease, or those needing long-term antibiotics that affect the gut.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Preparation
Feces are collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens.
Treatment
Subjects undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces within a 28-day window following engraftment.
Follow-up
Subjects are monitored for development of CDI, infections, and graft-versus-host disease. Fecal specimens are collected serially and analyzed for microbial diversity and composition.
Treatment Details
Interventions
- Autologous Fecal Microbiota Transplantation (Auto-FMT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor