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Fecal Transplant for MDR Pathogen Decolonization

This study is not yet open for participant recruitment.
Verified September 2016 by University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906774
First Posted: September 20, 2016
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  Purpose
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.

Condition Intervention
Multi-antibiotic Resistance Biological: Fecal microbiota transplantation (FMT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Estimate the proportion of patients who become re-colonized following FMT. [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Stool specimens from FMT donors and recipients.

Estimated Enrollment: 36
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Fecal microbiota transplantation (FMT)
    Fecal microbiota transplantation after antibiotic pretreatment
Detailed Description:
Contact the study principal investigator for the study protocol.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906774


Contacts
Contact: Amee Manges, MPH, PhD 604 707 2743 amee.manges@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z9
Contact: Amee Manges, MPH, PhD    604 707 2743    amee.manges@ubc.ca   
Principal Investigator: Amee Manges, MPH, PhD         
Principal Investigator: Theodore Steiner, MD         
Principal Investigator: Alissa Wright, MSc, MD         
Principal Investigator: Jennifer Grant, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Amee Manges, MPH, PhD University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02906774     History of Changes
Other Study ID Numbers: H15-01944
First Submitted: August 8, 2016
First Posted: September 20, 2016
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided