Fecal Transplant for MDRO Decolonization

Fecal Microbiota Transplantation (FMT) for Intestinal Decolonization of Multidrug-resistant Opportunistic Pathogens

This is a trial 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 using 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.

Study Overview

• Status: Recruiting
• Conditions: Multi-antibiotic Resistance
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation (FMT)

Detailed Description

Contact the study principal investigator for the study protocol.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amee Manges, MPH, PhD; Phone Number: 604 707 2743; Email: amee.manges@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Active, not recruiting
      • Providence Health Care - St. Paul's Hospital
    • Vancouver, British Columbia, Canada
      • Recruiting
      • Vancouver Coastal Health - Vancouver General Hospital
      • Contact: Theodore Steiner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Renal transplant patient inclusion criteria:

• 18 years or older
• Able to provide informed consent
• Positive for one of the target MDRO 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)
• Presence of colostomy or ileostomy
• Has an active intestinal infection
• Fever > 38.0 or white blood count (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, extended spectrum beta-lactamase (ESBL) producing organisms 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal microbiota transplantation	Biological: Fecal Microbiota Transplantation (FMT); FMT using retention enema
Experimental: Fecal microbiota transplantation with antibiotic pre-treatment	Biological: Fecal Microbiota Transplantation (FMT); FMT using retention enema
No Intervention: No intervention follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare proportions, type and timing of adverse events post-FMT	3 years
Proportions of recolonization over 180 days	3 years
Timing of recolonization over 180 days	3 years

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation
• Other Study ID Numbers: H19-00782 FMT.MDRO.RCT.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No