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NCT03229967 · ClinicalTrials.gov registry record
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
A clinical trial, sponsored by University of Tennessee.
- Completed
- Registry status
- 197
- Enrollment target
NCT03229967 is a clinical trial that has completed, run by University of Tennessee. The registered enrollment target is 197 participants.
The verdict
NCT03229967 has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- 197 participants
- Enrollment target
Study Summary
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria that naturally live in the gut, and determine if the relative diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the investigators propose to characterize the microbiota of human premature newborns with BPD, then validate this potential mechanism in mice. The investigators will enroll very low birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be obtained weekly over the first month of life. Infants that eventually develop BPD will be paired with infants that did not develop BPD. Stool samples from these infants will be sent for analysis. The investigators expect that reduced complexity of the gut microbiome is associated with BPD. The investigators will model the contribution of reduced microbiome complexity to the risk to develop BPD or death, as well as the association with disease severity. The project investigates important factors leading to the development of BPD, and has the potential to directly translate to therapy for the most significant pulmonary complication of prematurity.
Interventions
- DIAGNOSTIC_TEST 16S rRNA stool microbiome sequencing.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2020-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229967
The ClinicalTrials.gov registry entry for NCT03229967 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 16S rRNA stool microbiome sequencing. is the first listed.
NCT03229967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03229967 about?
NCT03229967 is a clinical study titled "Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia". The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria tha...
What is the current status of trial NCT03229967?
This trial is currently completed. The enrollment target is 197 participants. The study started on 2017-07-05. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT03229967?
The interventions under investigation include: 16S rRNA stool microbiome sequencing. (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03229967?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
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