Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis Clearance of ARO

• Status: Active, not recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vancouver Island Health Authority
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents

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