NCT02816437

FMT for MDRO Colonization in Solid Organ Transplant

Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.

Detailed description

This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections. Study participants who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. Participants will be followed from the time of enrollment up to 3 months post FMT. Specific organisms of interest that will be tested for by the stool cultures include vancomycin resistant enterococcus, carbapenem resistant Enterobacteriaceae and carbapenem resistant Pseudomonas. Eligible patients who demonstrate colonization with a positive culture for a specific organism of interest will be given FMT. One FMT dose of a retention rectal enema (OpenBiome) will be administered by a nurse and supervised by our principal investigator and/or sub-investigators trained in performance of FMT. Stool samples of study participants will be collected and analyzed as follows: * Pre-FMT: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice * 48 hours post FMT: Stool collection using RNA later kit provided by OpenBiome (in hospital) * Day 7: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice * Day 14: Stool collection using RNAlater kit (at home) * Day 30: Stool collection \& storage in glycerol/flash frozen (in hospital or clinic), to be shipped in dry ice * Day 90: follow-up visit in clinic, final sample collected using RNAlater kit

Conditions

• Infection Due to Resistant Organism

Interventions

Type	Name	Description
BIOLOGICAL	OpenBiome Fecal Microbiota Transplantation retention enema	Keep enema frozen until ready for administration. A single transfer of all 250mL of fecal material using universal precautions to a standard retention enema bag over 1 hour with material retained for at least 1 hour.

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2016-06-28
• Last updated: 2020-05-26