Recruiting

Fecal Transplant

Sponsor:

University of British Columbia

Code:

NCT04181112

Conditions

Multi-antibiotic Resistance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation (FMT)

Study Details

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.

Conditions

Multi-antibiotic Resistance

Study ID

NCT04181112

Start date

Nov 4, 2019

Status verified date

Oct, 2021

Completion date

Nov, 2023

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fecal microbiota transplantation

experimental: Fecal microbiota transplantation with antibiotic pre-treatment

no intervention: No intervention follow-up

Interventions

Fecal Microbiota Transplantation (FMT)

FMT using retention enema

Primary outcome measure

  • 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. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Amee Manges, MPH, PhD

604 707 2743amee.manges@ubc.ca

Locations

Vancouver Coastal Health - Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

More Information

Sponsor

University of British Columbia

Last update posted

Oct 6, 2021

Last verified

Oct, 2021

Keywords

  • Fecal Microbiota Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-10-06.