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NCT03043339 · ClinicalTrials.gov registry record
Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
A clinical trial, sponsored by Emory University.
- Terminated
- Registry status
- 3
- Enrollment target
NCT03043339: Clinical Trial study, sponsored by Emory University.
NCT03043339 is a clinical trial that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03043339 was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
This is a hypothesis-generating pilot study. The intent is to model the impact of perioperative practices on the intestinal microbiome and possibly associate these conditions with the final microbiome status (e.g., number of resistance genes and diversity associated with perioperative practices and preoperative microbiome status). Participants will include individuals who are having surgery to either receive or donate a kidney. To determine the diversity change of the intestinal microbiota over time, rectal swabs will be collected before surgery and at several time points after surgery, with the last swab collected 30 days after surgery. This pilot study is to obtain preliminary data to support the rationale and design for a subsequent clinical trial. This study is designed to understand the intestinal microbiota diversity in the setting of renal transplant surgery and the clinical significance of antibiotic use and the associated resistome (collection of all antibiotic resistance genes and precursors within a sample).
Primary Outcome
To understand the overall impact of surgical prophylaxis on intestinal microbiota composition in the setting of renal transplant surgery, the distribution and relative abundance of bacterial and fungal taxa for each collected sample will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
Interventions
- OTHER Stool Specimen Collection
- OTHER Anal Swab Sampling
- OTHER Short Diet Assessment (SDA)
- OTHER NHANES Dietary Screener Questionnaire (DSQ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2019-01-10 |
Why NCT03043339 stopped before completion
NCT03043339 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Stool Specimen Collection is the first listed.
NCT03043339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03043339 about?
NCT03043339 is a clinical study titled "Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt". This is a hypothesis-generating pilot study. The intent is to model the impact of perioperative practices on the intestinal microbiome and possibly associate these conditions with the final microbiome status (e.g., number of resistance genes and diversity associated with perioperative practices and ...
What is the current status of trial NCT03043339?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2017-10-02. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT03043339?
The interventions under investigation include: Stool Specimen Collection (OTHER), Anal Swab Sampling (OTHER), Short Diet Assessment (SDA) (OTHER), NHANES Dietary Screener Questionnaire (DSQ) (OTHER).
Who is sponsoring clinical trial NCT03043339?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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