NCT04181112

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

November 26, 2019

Last Update Submit

October 4, 2021

Conditions

Multi-antibiotic Resistance

Keywords

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Fecal microbiota transplantation

EXPERIMENTAL
Biological: Fecal Microbiota Transplantation (FMT)

Fecal microbiota transplantation with antibiotic pre-treatment

EXPERIMENTAL
Biological: Fecal Microbiota Transplantation (FMT)

No intervention follow-up

NO INTERVENTION

Interventions

Fecal Microbiota Transplantation (FMT)BIOLOGICAL

FMT using retention enema

Fecal microbiota transplantationFecal microbiota transplantation with antibiotic pre-treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Able to provide informed consent
  • Positive for one of the target MDRO 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)
  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence Health Care - St. Paul's Hospital

Vancouver, British Columbia, Canada

ACTIVE NOT RECRUITING

Vancouver Coastal Health - Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Central Study Contacts

Amee Manges, MPH, PhD

CONTACT

604 707 2743amee.manges@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

November 4, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2023

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

CA(2)