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Microbiome Restoration Therapy

Fecal Microbiota Transplant (FMT) for Antimicrobial Resistance Infection (PREMIX Trial)

Phase 1
Waitlist Available
Led By Colleen S Kraft, MD, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, up to 30 weeks
Awards & highlights

PREMIX Trial Summary

This trial will test the safety of a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, in kidney transplant patients who have infections with resistant bacteria. The study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics.

Eligible Conditions
  • Antimicrobial Resistance Infection

PREMIX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, up to 30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, up to 30 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Target MDRO Growth
Number of Adverse Events

Side effects data

From 2019 Phase 1 & 2 trial • 15 Patients • NCT02330653
17%
Non-Cardiac Chest Pain
17%
Abnormal Lab Values
17%
Grade 3 Colitis
17%
Eczema/Rash
8%
Sore Throat
8%
Upper Respiratory Infection
8%
Fever
8%
Epiploic Appendagitis
8%
Grade 3 Sinus Tachycardia
8%
Eye Disorder/Blurred Vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplant (FMT)
Placebo

PREMIX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fecal Microbiota Transplant (FMT)Experimental Treatment4 Interventions
The experimental arm will participate in the bowel preparation, stool or perirectal swab sampling, and will receive Fecal Microbiota Transplant (FMT) using Allogeneic Human Stool in Glycerol 10% (AHSG) on Day 1 of each cycle (Cycles 1 and 2).
Group II: Control armPlacebo Group2 Interventions
The control arm will participate in the bowel preparation and stool or perirectal swab sampling but will not receive Fecal Microbiota Transplant (FMT) nor will they be fasting during their first study cycle (Cycle 0). Participants testing positive for a multi-drug resistant organism at the of Cycle 0 will be eligible to receive microbiota restoration transplant (MRT) for up to two cycles, as necessary (Cycles 1 and 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant (FMT)
2015
Completed Phase 2
~80
Bowel preparation
2013
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,521 Total Patients Enrolled
CepheidIndustry Sponsor
19 Previous Clinical Trials
8,707 Total Patients Enrolled
Colleen S Kraft, MD, MScPrincipal InvestigatorEmory University
2 Previous Clinical Trials
210 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Infectious DiseasesJournal
An Ounce of Prevention Is Equivalent to How Much Decolonization Exactly?
Woodworth, Michael H, Jennie H Kwon, and Colleen S Kraft. 2020. “An Ounce of Prevention Is Equivalent to How Much Decolonization Exactly?”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciaa1524.
clinicaltrials.govStudy
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
Colleen S. Kraft 2016. "FMT for MDRO Colonization After Infection in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02922816.
~1 spots leftby Apr 2025
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