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

  • STATUS
    Recruiting
  • End date
    Jan 20, 2028
  • participants needed
    200
  • sponsor
    Emory University
Updated on 20 April 2022
microbiota

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.

Description

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.

Details
Condition Clostridium Difficile Infection
Treatment Microbiota Enrichment Program (MEP)
Clinical Study IdentifierNCT03350711
SponsorEmory University
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note