Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis Clearance of ARO

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy of FMTs via enema for 1) symptom improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory bowel disease or irritable bowel syndrome; 2) clearance of antimicrobial resistant organism from the gastrointestinal tract.

Detailed Description
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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.

Official Title
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Prospective, Open-label Trial to Evaluate Efficacy of Fecal Microbiota Transplantation for Treatment of Chronic Gastrointestinal Dysbiosis or Clearance of Antimicrobial Resistant Organism.

Conditions
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Dysbiosis, Antimicrobial Resistant Organism

Intervention / Treatment
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* Drug: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Fecal Microbiota Transplantation | Drug: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation Enema Open Label<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment | Symptom improvement in formal diagnosis of dysbiosis or clearance of antimicrobial resistant organism | 2 years |