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NCT02922816 · ClinicalTrials.gov registry record · Phase 1
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02922816 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 11 participants.
The verdict
NCT02922816, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Fasting
- BIOLOGICAL Fecal Microbiota Transplant (FMT)
- PROCEDURE Bowel preparation
- PROCEDURE Stool or perirectal swab sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-12-01 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02922816
The ClinicalTrials.gov registry entry for NCT02922816 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fasting is the first listed.
NCT02922816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02922816 about?
NCT02922816 is a clinical study titled "FMT for MDRO Colonization After Infection in Renal Transplant Recipients". 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 hav...
What is the current status of trial NCT02922816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-12-01. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT02922816?
The interventions under investigation include: Fasting (OTHER), Fecal Microbiota Transplant (FMT) (BIOLOGICAL), Bowel preparation (PROCEDURE), Stool or perirectal swab sampling (PROCEDURE).
Who is sponsoring clinical trial NCT02922816?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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