TerminatedPhase 1

FMT for MDRO Colonization After Infection in Renal Transplant Recipients

Stopped: This study was paused and was not resumed due to the COVID-19 pandemic.

United States11 participantsStarted 2016-12-01

Plain-language summary

Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics. This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to understand and willingness to sign a written informed consent document. * Ability and willingness to comply with study protocol requirements and receive an enema. * History of MDRO infection with at least one of the following target MDROs: CRE, VRE, ESBL, or MDR Pseudomonas. * Prior receipt of a renal transplant. * If applicable, willingness to discontinue probiotics or other microbiota restoration therapies during screening at least seven days prior to study Day 1. * The effects of FMT on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Negative blood or urine human chorionic gonadotropin (hCG) testing on the day of FMT for WOCBP with documentation of negative test result. * Negative baseline Human Immunodeficiency Virus (HIV) test. * Known serology CMV status confirmed by Medical History (if positive). If no mention of positivity in medical records, serology is tested within 30 days of enrollment for: * Cytomegalovirus (CMV) by polymerase chain reaction (PCR) * Cytomegalovirus (CMV), serology Immunoglobulin G (IgG) Exclusion Criteria: * Female participants who are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product). * Pr…

What they're measuring

Number of Adverse Events

Timeframe: Up to 30 weeks

Change in Target MDRO Growth

Timeframe: Day 1, Up to 30 weeks

Trial details

NCT IDNCT02922816

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-03