CompletedPhase 1

Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

United States7 participantsStarted 2017-07-10

Plain-language summary

This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
✓. Adults (18 years or older)

Exclusion criteria

✕. Pregnant. Participants of childbearing age will undergo urine pregnancy testing
✕. Participant or substitute decision maker unable to provide informed consent
✕. Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
✕. Current enrollment in hospice
✕. Colostomy
✕. Unable to adhere to protocol requirements
✕. Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
✕. Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system

What they're measuring

Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization

Timeframe: Day 7 after randomization

Trial details

NCT IDNCT03061097

SponsorMicrobiome Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-19

Results submitted2020-11-11

View on ClinicalTrials.gov More Antibiotic Resistant Strain trials