Fecal Transplant for MDR Pathogen Decolonization

NCT02906774 | Terminated

• 1 other identifier: H15-01944
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Multi-antibiotic Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

Fecal microbiota transplantation (FMT) BIOLOGICAL

Fecal microbiota transplantation after antibiotic pretreatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• Able to provide informed consent
• Positive for one of the target MDR organisms by rectal or stool culture tests
• Able to provide informed consent
• Able to complete donor screening
• Able to adhere to FMT stool collection and testing procedures

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool specimens from FMT donors and recipients.

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Amee Manges, MPH, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: September 20, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CA (1)