- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906774
Fecal Transplant for MDR Pathogen Decolonization
November 27, 2019 updated by: Amee Manges, University of British Columbia
A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Contact the study principal investigator for the study protocol.
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z9
- University of British Columbia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)).
Time Frame: 6 months
|
6 months
|
Estimate the proportion of patients who become re-colonized following FMT.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amee Manges, MPH, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
November 1, 2019
Study Completion (ACTUAL)
November 1, 2019
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
September 14, 2016
First Posted (ESTIMATE)
September 20, 2016
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- H15-01944
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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