Multi-antibiotic Resistance
Conditions
Brief summary
This is a proof-of-principle research study 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 by 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)
Fecal microbiota transplantation after antibiotic pretreatment
Sponsors
University of British Columbia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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 MDR organisms 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) * Colonized with Clostridium difficile * Presence of colostomy or ileostomy * Has an active intestinal infection * Fever \> 38.0 or 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 primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)). | 6 months |
| Estimate the proportion of patients who become re-colonized following FMT. | 6 months |
Countries
Canada
Outcome results
None listed