Clinical trial NCT02906774: Fecal Transplant for MDR Pathogen Decolonization
Official title: A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multi-antibiotic Resistance
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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)).
timeFrame: 6 months
measure: Estimate the proportion of patients who become re-colonized following FMT.
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Amee Manges, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: