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FMT for MDRO Colonization in Solid Organ Transplant

NCT02816437 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-05-26

No results posted yet for this study

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.

Conditions

  • Infection Due to Resistant Organism

Interventions

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Lilian Abbo, M.D · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-10-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02816437 on ClinicalTrials.gov