NCT02922816: PREMIX

FMT for MDRO Colonization After Infection in Renal Transplant Recipients

Terminated Phase 1 Last updated 15 November 2023

What this trial tests

Phase 1 trial testing Fecal Microbiota Transplant (FMT) in Infection Due to Resistant Organism in 11 participants. Terminated before completion.

Timeline

1 December 2016

Primary endpoint
3 December 2021

3 December 2021

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 December 2016
Primary completion	3 December 2021
Estimated completion	3 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Fecal Microbiota Transplant (FMT) — full drug profile →
• Bowel preparation — full drug profile →
• Stool or perirectal swab sampling
• Fasting

Conditions studied

• Infection Due to Resistant Organism — all drugs for Infection Due to Resistant Organism →

Sponsor

Emory University

Who can join

18 and older, any sex, with Infection Due to Resistant Organism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics.

This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
2. Fecal microbiota transplantation promotes reduction of antimicrobial resistance by strain replacement.
   Woodworth MH, Conrad RE, Haldopoulos M, Pouch SM, et al · · 2023 · cited 87× · PMID 37910603 · DOI 10.1126/scitranslmed.abo2750
3. Microbial metabolite delta-valerobetaine is a diet-dependent obesogen.
   Liu KH, Owens JA, Saeedi B, Cohen CE, et al · · 2021 · cited 55× · PMID 34931082 · DOI 10.1038/s42255-021-00502-8
4. Gut Microbiota Modulation for Multidrug-Resistant Organism Decolonization: Present and Future Perspectives.
   Gargiullo L, Del Chierico F, D'Argenio P, Putignani L. · · 2019 · cited 54× · PMID 31402904 · DOI 10.3389/fmicb.2019.01704
5. Large scale enzyme based xenobiotic identification for exposomics.
   Liu KH, Lee CM, Singer G, Bais P, et al · · 2021 · cited 39× · PMID 34521839 · DOI 10.1038/s41467-021-25698-x
6. Gut Microbiota Modulation and Prevention of Dysbiosis as an Alternative Approach to Antimicrobial Resistance: A Narrative Review.
   Matzaras R, Nikopoulou A, Protonotariou E, Christaki E. · · 2022 · cited 34× · PMID 36568836
7. The potential utility of fecal (or intestinal) microbiota transplantation in controlling infectious diseases.
   Ghani R, Mullish BH, Roberts LA, Davies FJ, et al · · 2022 · cited 29× · PMID 35230889 · DOI 10.1080/19490976.2022.2038856
8. Is there a role of faecal microbiota transplantation in reducing antibiotic resistance burden in gut? A systematic review and Meta-analysis.
   Dharmaratne P, Rahman N, Leung A, Ip M. · · 2021 · cited 17× · PMID 34170204 · DOI 10.1080/07853890.2021.1927170