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

NCT03350711 | Suspended

• 1 other identifier: IRB00098240
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Microbiota composition; Microbiota Enrichment Program; Fecal microbiota transplant (FMT)

Outcome Measures

Primary Outcomes (1)

• To determine if the creation of a database will improve enrollment onto other research studies

  Successful creation of the database will be defined as capturing demographic and medical information about persons reaching out to obtain FMT in order to screen them for current and upcoming protocols within MEP.

  Ten years

Study Arms (1)

Microbiota Enrichment Program (MEP)

Patients who are seeking a fecal microbiota transplant (FMT), for any reason, who will be part of a registry of patients to potentially screen for a FMT study.

Other: Microbiota Enrichment Program (MEP)

Interventions

Microbiota Enrichment Program (MEP) OTHER

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.

Microbiota Enrichment Program (MEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment for this study will be done using Emory's data warehouse, subjects with a diagnosis of Clostridium difficile infection (CDI), or subjects that contact Emory with interest in FMT, as well as through referrals from local doctor's offices, and subjects who self-refer to the Emory Microbiota Enrichment Program (MEP)

You may qualify if:

• Age of at least 18 years
• Seeking services that are affiliated with the Emory Microbiota Enrichment Program (MEP) for any reason, such as:
• Clinical services, interventions, or procedures (e.g., FMT), or
• Research studies
• Able to understand and approve the informed consent and HIPAA authorizations forms verbally on the phone or by signature in-person

You may not qualify if:

• Known or suspected terminal disease

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

The Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Colleen Kraft, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 22, 2017
• Study Start: September 13, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (3)