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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 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.

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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.

Interventions

  • BIOLOGICAL Vaginal Seeding
  • OTHER No Vaginal Seeding

Study Locations (1)

Virginia

  • Inova Health System - Falls Church

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2018-07-01
Est. Completion 2029-04
Phase Phase 1

What the Registry Record Tells You About NCT03298334

The ClinicalTrials.gov registry entry for NCT03298334 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 332-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (81% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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