Status:
TERMINATED
Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO
Lead Sponsor:
Vancouver Island Health Authority
Conditions:
Dysbiosis
Antimicrobial Resistant Organism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to assess the efficacy of FMTs via rectal administration for 1) symptom improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory bowel ...
Detailed Description
Fecal Microbiota Transplantation (FMT), which had been predominantly utilized by the veterinarians until late 1990's has generated a significant interest for its potential use in various gastrointesti...
Eligibility Criteria
Inclusion
- 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
- 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, shiga toxin-producing E. coli, 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03834051
Start Date
February 1 2019
End Date
July 8 2020
Last Update
March 18 2024
Active Locations (1)
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1
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8