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Clinical Trials

Looking for a clinical trial?  Please see what active studies we have and contact us!

PREMIX

A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization after Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design

Full Study Title

Indication

Seeking those that have received a renal transplant and have a history of MDRO infection.

Research Program Study

Outpatient FMT via enema to treat multiple drug resistant organisms (MDRO's) in renal transplant patients and achieve 36 days with negative stool tests. Patients will be followed for 24 weeks (4 visits to The Emory Clinic and at least 6 phone calls). Participants are asked (but not required) to collect stool samples at 4 time points to be collected by courier from their home. Participants will be asked to keep a log of bowel movements for first few weeks and refrain from probiotics for the entirety of the study.


Adults with a history of  multidrug resistant (MDR) infections

Patient Population

Clinical Program /

Mode of Treatment

Enema - FMT

SERES-016

Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides difficile Infection (RCDI)

Full Study Title

Indication

Seeking those who have had ≥ 2 lifetime confirmed episodes of CDI, inclusive of the current episode and are not presently receiving antibiotic treatment


Research Program Study

Study will involve two visits to Emory (Screening/Pre-enrollment visit and the Day 1 Dosing visit)


Treatment will consist of four pills , taken three days in a row. Dosing for Day 1 will be in clinic


Subjects will be followed for safety monitoring for 24 weeks, via monthly phone calls, to assess for adverse events of special interest (AESIs) and/or SAEs

Adults with recurrent C. difficile infection

Patient Population

Clinical Program /

Mode of Treatment

Expanded Access pill study containing firmicute spores derived from healthy donor stool

PROTECT

Bacillus velezensis DSM 33864 for reduction of the risk of recurrent Clostridioides difficile infections

Full Study Title

Indication

Seeking those with medical record documentation of second episode of CDI who are not presently receiving antibiotic therapy

Research Program Study

Treatment will consist of one pill taken each day with breakfast for eight weeks. Dosing for Day 1 will take place the morning after the Baseline visit. All supplementation will be taken in the patient’s home. Study will involve five visits. Four of these visits (Screening, Baseline, End of Supplementation and a 12 week follow-up visit) will be at Emory. The Week 4 visit will be conducted by phone. Subjects will be followed for safety monitoring for 4 weeks. There will be four stool sample collections and three blood draws in this study as well as the use of paper-based questionnaires and the use of study diary for the duration of the study.

Adults with recurrent C. difficile infection

Patient Population

Clinical Program /

Mode of Treatment

Pill - FMT

Interested?

Do you want more information on a clinical trial or do not see one that pertains to you?  Please fill out the form below to get in contact with us!

Contact Form
C. Diff
MDRO
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