FMT for MDRO Colonization in Solid Organ Transplant

Phase 1

Withdrawn

• Conditions: Infection Due to Resistant Organism
• Interventions: Biological: OpenBiome Fecal Microbiota Transplantation retention enema

• Registration Number: NCT02816437
• Lead Sponsor: University of Miami

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-07
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-26
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OpenBiome FMT retention enema	OpenBiome Fecal Microbiota Transplantation retention enema	OpenBiome Fecal Microbiota Transplantation retention enema, one rectal application.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	10 months	Overall rates of adverse events

Secondary Outcome Measures

Name	Time	Method
Rate of MDRO decolonization	10 months	Number of successful cases of MDRO decolonization
Rate of Recurrent MDRO infections	10 months	Number of patients with recurrent MDRO infections