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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.
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. [ Time Frame: 6 months ]
Secondary Outcome Measures :
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)). [ Time Frame: 6 months ]
Estimate the proportion of patients who become re-colonized following FMT. [ Time Frame: 6 months ]
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Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Renal transplant patients who are intestinally colonized with any of the target MDR organisms based on rectal culture screening according to Provincial Infection Control Network of British Columbia guidelines and performed by the Vancouver General Hospital Clinical Laboratory will be eligible.
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
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 exclusion criteria:
Presence of any of the following by stool examination: vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia, Campylobacter, ESBL or carbapenemase-producing Enterobacteriaceae (CRE), pathogenic ova or parasites, C. difficile toxin B (by PCR), or rotavirus, adenovirus and norovirus
History of any type of active cancer aside from melanoma
Risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea, or colostomy or ileostomy
Receipt of blood transfusion from a country other than Canada in the preceding 6 months
Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
Receipt of any live vaccine within 3 months prior to stool donation
Any current or previous medical or psychosocial condition or behaviors which in the opinion of the investigator may pose risk to the recipients or the donor