Multi-antibiotic Resistance
Conditions
Keywords
Fecal Microbiota Transplantation
Brief summary
This is a trial designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT using enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.
Detailed description
Contact the study principal investigator for the study protocol.
Interventions
BIOLOGICALFecal Microbiota Transplantation (FMT)
FMT using retention enema
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Renal transplant patient inclusion criteria: * 18 years or older * Able to provide informed consent * Positive for one of the target MDRO by rectal or stool culture tests FMT stool donor inclusion criteria: * Able to provide informed consent * Able to complete donor screening * Able to adhere to FMT stool collection and testing procedures Renal transplant patient
Exclusion criteria
* Still in hospital at week 7 following organ transplantation * Pregnant or planning to become pregnant * Breastfeeding * Participating in another interventional or investigational study * Neutropenic (ANC \< 0.5) * Presence of colostomy or ileostomy * Has an active intestinal infection * Fever \> 38.0 or white blood count (WBC) count \> 15,000 * Are taking a non-dietary probiotic supplement * Require or are expected to require systemic antimicrobial therapy other than Pneumocystis prophylaxis or cytomegalovirus (CMV) therapy during the study period * Has a severe underlying disease with anticipated survival less than 6 months * Are unable to tolerate FMT or enema for any reason, or where their physician believes for any reason that FMT might pose a health risk to the subject * Subjects who report a history of anaphylactoid food allergy will not be excluded but these allergies will be noted and donors will be required to avoid ingestion of these foods for at least three days prior to donation FMT stool donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare proportions, type and timing of adverse events post-FMT | 3 years |
| Proportions of recolonization over 180 days | 3 years |
| Timing of recolonization over 180 days | 3 years |
Countries
Canada
Contacts
Primary ContactAmee Manges, MPH, PhD
Outcome results
None listed