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NCT05505110 · ClinicalTrials.gov registry record · Early Phase 1

MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

A Early Phase 1 study of Microbiome and C-section, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT05505110 is a Early Phase 1 study of Microbiome and C-section that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 20 participants, below the 141-participant average among 12 other Microbiome trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05505110, a Early Phase 1 study of Microbiome and C-section, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of children born by cesarean section (C-section) is feasible and that the intervention is safe.

Interventions

  • BIOLOGICAL Vaginal Seeding
  • OTHER Sterile Swab

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-11-09
Est. Completion 2028-08-10
Phase Early Phase 1

What the Registry Record Tells You About NCT05505110

The ClinicalTrials.gov registry entry for NCT05505110 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 12 other Microbiome trials with a reported enrollment target (86% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Microbiome appearing as the primary indexed condition, and to 2 interventions - of which Vaginal Seeding is the first listed.

NCT05505110 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT05505110 about?

NCT05505110 is a clinical study titled "MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing". This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention ...

What is the current status of trial NCT05505110?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2022-11-09. Estimated completion is 2028-08-10.

What conditions does trial NCT05505110 study?

This clinical trial studies the following conditions: Microbiome, C-section, Vaginal Seeding, Respiratory.

What interventions are being tested in trial NCT05505110?

The interventions under investigation include: Vaginal Seeding (BIOLOGICAL), Sterile Swab (OTHER).

Who is sponsoring clinical trial NCT05505110?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05505110 being conducted?

This trial has 1 study location across Tennessee. 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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