FMT for MDRO Colonization After Infection in Renal Transplant Recipients

PHASE1TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 1, 2016

Primary Completion Date

December 3, 2021

Study Completion Date

December 3, 2021

Conditions
Infection Due to Resistant Organism
Interventions
BIOLOGICAL

Fecal Microbiota Transplant (FMT)

The Fecal Microbiota Transplant (FMT) using Allogeneic human stool in glycerol (10%) (AHSG) intervention will be administered via rectal retention enema and performed in either an inpatient or outpatient clinic.

PROCEDURE

Bowel preparation

Trial participants will undergo the bowel preparation by taking magnesium citrate the day before the cycle begins (Day -1).

PROCEDURE

Stool or perirectal swab sampling

Stool or perirectal swabs will be collected at screening (for eligibility determination) and Days 1, 2, 15, and 36 of each cycle.

OTHER

Fasting

In Cycle 1 and Cycle 2, participants cannot consume food, alcohol, or other liquids on Day 1 prior to the intervention. Trial participants will not be fasting on Day 1 of Cycle 0.

Trial Locations (1)

30324

Emory University Hospital, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cepheid

INDUSTRY

lead

Emory University

OTHER