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NCT03298334 · ClinicalTrials.gov registry record · Phase 1
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
A Phase 1 study of Obesity, Childhood and Microbiota, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT03298334: Recruiting Phase 1 study of Obesity, Childhood and Microbiota, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03298334 is a Phase 1 study of Obesity, Childhood and Microbiota that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants, above the 332-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (81% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03298334, a Phase 1 study of Obesity, Childhood and Microbiota, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study Summary
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
Primary Outcome
E.g. Body mass index z-score
Conditions Studied
Interventions
- BIOLOGICAL Vaginal Seeding
- OTHER No Vaginal Seeding
Study Locations (1)
Virginia
- Inova Health System - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2029-04 |
| Phase | Phase 1 |
What NCT03298334 shows while recruiting
NCT03298334 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 332-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (81% higher).
The record links to 6 conditions, with Obesity, Childhood appearing as the primary indexed condition, and to 2 interventions - of which Vaginal Seeding is the first listed.
NCT03298334 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03298334 about?
NCT03298334 is a clinical study titled "Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.". Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and an...
What is the current status of trial NCT03298334?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2018-07-01. Estimated completion is 2029-04.
What conditions does trial NCT03298334 study?
This clinical trial studies the following conditions: Obesity, Childhood, Microbiota, Gastrointestinal Microbiome, Cesarean Delivery Affecting Newborn, Intestinal Microbiome.
What interventions are being tested in trial NCT03298334?
The interventions under investigation include: Vaginal Seeding (BIOLOGICAL), No Vaginal Seeding (OTHER).
Who is sponsoring clinical trial NCT03298334?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03298334 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03298334's enrollment target sits among peer trials
600 9th of 53 higher than 45 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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