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

The unintended consequence of the development of life-saving antimicrobial therapies has been
the havoc that is wreaked on the patient's intestinal microbiota. Clostridium difficile
infection (CDI) has been found to be the causative agent of 15%-25% of all cases of
antibiotic-associated diarrhea, with increasing severity in those with advanced age and who
are hospitalized for other reasons. Despite resolution of symptoms in patients treated with
antimicrobials, there remains an ~20% CDI recurrence rate. Furthermore, patients who
experience a first recurrence have a 40% risk of an additional recurrence and those with two
or more episodes face a 60% risk. As a result, there are substantial numbers of patients who
live with chronic and debilitating diarrhea from CDI despite repeated courses of prolonged
therapy. C. difficile infection represents an important clinical syndrome and development of
new preventive and therapeutic strategies are a key unmet medical need.

Fecal microbiota transplant (FMT), which is defined as the transfer of the feces from one
individual (donor) into another individual (recipient), has recently become more standardized
and acceptable for the treatment of C. difficile. The first randomized controlled trial (RCT)
was published in January of 2013 and compared duodenal infusion FMT after oral vancomycin as
compared to oral vancomycin alone and for the treatment of recurrent C. difficile. The trial
showed excellent efficacy for FMT, along with restoration of the diversity of the microbiota
in the recipients. Even prior to this RCT, case series with over 200 patients had shown
excellent efficacy with one FMT, with rates of success almost to 90% when patients received
two FMTs.

Emory's Fecal Transplant Program was started in 2012, and since then has performed 280 FMTs
in inpatient and outpatient settings. The Emory Microbiota Enrichment Program (MEP) came into
existence in 2016 in order to provide a clinical research infrastructure to recruit subjects
into clinical research studies related to the microbiome. The goal of this protocol is to
create an electronic database capture with a survey to capture demographic and medical
information about subjects reaching out to obtain FMT for a variety of reasons and, if
needed, pre-screen these subjects for current and upcoming protocols within MEP. A list of
potential participants will be generated using the Emory University Data Warehouse to
identify subjects with CDI and other conditions that could benefit from the Emory MEP.
Advertisements will be placed in the community as a recruitment tool and individuals that
contact Emory will be connected to the study recruiter. The recruiters will review the
eligibility criteria for inclusion in the MEP database as well as the inclusion and exclusion
criteria for all of the enrolling FMT studies currently underway at the Hope Clinic and Emory
University Hospitals. If the subject meets the inclusion criteria for one of the Emory FMT
studies, they will be invited for a general screening visit or a study specific screening
visit for a specific MEP protocol.

The duration of the study varies for each subject and participation is indefinite unless one
of the following occurs:

- A subject is rendered ineligible

- The screening is completed, and a subject is referred to a specific MEP study.

- A subject withdraws consent to participate in this study, which may be done verbally or
by revocation letter. Additional details will be requested to determine if the
participant either no longer wants to perform any MEP related activities (e.g., MEP
survey) or revokes the future use of protected health information (PHI) and medical
chart review during follow-up.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Known or suspected terminal disease