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A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program

NCT03350711 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-05-22

No results posted yet for this study

Summary

The goal of this study is to rapidly identify subjects who are eligible for the Microbiota Enrichment Program (MEP) at Emory in Atlanta, Georgia. This general screening protocol will be used to screen potential subjects for the Emory MEP and will be conducted at the Emory Clinic, the Hope Clinic of the Emory Vaccine Center and/or Emory affiliated hospitals. An electronic database will be created to capture demographic and medical information about individuals who are reaching out to obtain fecal microbiota transplant (FMT) and pre-screen these potential study participants for current and upcoming studies within MEP.

Conditions

  • Clostridium Difficile Infection

Interventions

OTHER

Microbiota Enrichment Program (MEP)

Registry participants will provide demographic and medical information and may take part in general screening procedures to facilitate enrolling into an appropriate FMT study. Once determined to be eligible for study entry, study-specific screening procedures may include: * Health history and physical examination * Urinalysis * Urine or serum pregnancy test * Blood tests for Hepatitis B, Hepatitis C, HIV, chemistry panel (which includes liver function, kidney function), complete blood count with differential, platelet count, partial thromboplastin time (PTT), international normalized ratio (INR) * Electrocardiogram (EKG or ECG) * Stool studies Participants will be re-screened every 6 months and will remain in follow-up indefinitely or until they are rendered ineligible, participate in a MEP study, or withdraw consent to be included in the database.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Colleen Kraft, MD, MSc · Emory University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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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 NCT03350711 on ClinicalTrials.gov