Fecal Transplant for MDR Pathogen Decolonization

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae

Conditions
-----------------
Multi-antibiotic Resistance

Intervention / Treatment
-----------------
* Biological: Fecal microbiota transplantation (FMT)


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fecal microbiota transplantation (FMT)|Fecal microbiota transplantation after antibiotic pretreatment|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |