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Trial record 56 of 26556 for:    Anti-Infective Agents

Fecal Microbiota Transplantation for Clearance of Antimicrobial Resistant Organism (FMTGID)

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ClinicalTrials.gov Identifier: NCT03834051
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Vancouver Island Health Authority

Brief Summary:
The objective is clearance of antimicrobial resistant organism from the gastrointestinal tract.

Condition or disease Intervention/treatment Phase
Antimicrobial Resistant Organism Drug: Fecal Microbiota Transplantation Not Applicable

Detailed Description:

Since the formal implementation of fecal microbiota transplantation trials at St. Joseph's Healthcare Hamilton in 2012, there are daily phone calls and e-mails from patients with a variety of chronic gastrointestinal disorders such as ulcerative colitis, Crohns, chronic irritable bowel syndrome, chronic severe constipation due to dysbiosis, which are formally diagnosed by gastroenterologists who specialize in this disorder to request for FMT. Out of desperation, some of these patients have explored the option of performing FMT at home.

There are instructions on how to manufacture and perform home FMTs on the internet. Given this some patients may perform FMTs at home using stool samples from unscreened and/or inappropriate donors. Individuals with metabolic disorders, family history of colonic cancer, autoimmune disease, gastrointestinal disorders as well as the ones whose blood and stools are unscreened should be excluded from donating stools. Unsupervised and using stool samples from an unscreened or unsuitable donor can lead to undesirable immediate and long-term consequences. The real possibility of these patients performing FMTs at home using stool samples from unscreened donors is very concerning.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open-label Trial to Evaluate Efficacy of Fecal Microbiota Transplantation for Clearance of Antimicrobial Resistant Organism
Estimated Study Start Date : August 8, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label
Fecal Microbiota Transplantation
Drug: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation Enema




Primary Outcome Measures :
  1. Treatment [ Time Frame: 2 years ]
    Clearance of Antimicrobial Resistant Organism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Able to provide informed consent.
  • Willing and able to comply with all the required study procedures.
  • Rectally colonized with antimicrobial resistant organisms: Extended-spectrum of beta-lactamase, Carbapenem resistant, vancomycin resistant enterococci

Exclusion Criteria:

  • Planned or actively taking another investigational product
  • Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
  • Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
  • Peripheral white blood cell count > 30.0 x 109/L AND temperature > 38.0 ºC
  • Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
  • Unable to tolerate FMT or enema for any reason.
  • Requiring systemic antibiotic therapy at the time of FMT.
  • Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
  • Severe underlying disease such that the patient is not expected to survive for at least 30 days.
  • History of severe allergy to any food

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): NCT03834051


Contacts
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Contact: Chris Goldeh 2368822327 christiana.goldeh@viha.ca

Locations
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Canada, British Columbia
Vancouver Island Health Authority Recruiting
Victoria, British Columbia, Canada, V8R 1J8
Contact: Chris Goldeh         
Contact    2368822327    christiana.goldeh@viha.ca   
Sponsors and Collaborators
Vancouver Island Health Authority
Investigators
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Principal Investigator: Christine Lee Vancouver Island Health Authority

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Responsible Party: Vancouver Island Health Authority
ClinicalTrials.gov Identifier: NCT03834051     History of Changes
Other Study ID Numbers: FMT.ARO (C2017-072)
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents