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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: Recruiting Early Phase 1 study of Microbiome and C-section, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The study will be considered "definitively feasible as proposed," "possibly feasible as proposed," or "not feasible as proposed" based on eligibility, consent, enrollment, and loss to follow-up rates, which could be used as preliminary data to inform the design of a future phase II RCT. For this study, "enrolled" will be defined as consented and screened, with eligibility verified, and the eligibility, consent, enrollment, and loss to follow-up rates will be calculated using the following formul
Conditions Studied
Interventions
- BIOLOGICAL Vaginal Seeding
- OTHER Sterile Swab
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-11-09 |
| Est. Completion | 2028-08-10 |
| Phase | Early Phase 1 |
What NCT05505110 shows while recruiting
NCT05505110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 141-participant average among 12 other Microbiome trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05505110's enrollment target sits among peer trials
20 13th of 12 the lowest of 12 other Microbiome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbiome 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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