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Vaginal Seeding for Cesarean Section Babies (MOTHER SEED Trial)

N/A
Recruiting
Led By Christian Rosas-Salazar, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year following randomization

Summary

This trial tests if swabbing babies born by C-section with secretions from mom's vagina is safe and can modify their early-life microbiome.

Who is the study for?
This trial is for healthy infants born by C-section at VUMC, with mothers aged 18-40 intending to breastfeed and have pediatric care at VUMC. Exclusions include maternal infections like HIV or hepatitis, fever before delivery, use of certain antibiotics or immunosuppressives near delivery time, labor complications, and serious infant health issues.
What is being tested?
The study tests if swabbing a newborn's nose with vaginal secretions after a C-section can safely alter the baby's upper respiratory microbiome. Infants are randomly assigned to receive either the vaginal seeding treatment or a sterile swab as control.
What are the potential side effects?
As this is an observational study focusing on feasibility and safety of the intervention (vaginal seeding), specific side effects are not anticipated beyond typical risks associated with handling newborns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year following randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year following randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the RCT
Safety of the intervention
Secondary study objectives
Proportion of in-person study visits completed
Vagina
Timing of the intervention

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
Vaginal Seeding
Group II: Control GroupPlacebo Group1 Intervention
Sterile Swab

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,461 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,291 Total Patients Enrolled
1 Trials studying Microbiome
50 Patients Enrolled for Microbiome
Christian Rosas-Salazar, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Vaginal Seeding Clinical Trial Eligibility Overview. Trial Name: NCT05505110 — N/A
Microbiome Research Study Groups: Intervention Group, Control Group
Microbiome Clinical Trial 2023: Vaginal Seeding Highlights & Side Effects. Trial Name: NCT05505110 — N/A
Vaginal Seeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505110 — N/A
~18 spots leftby Aug 2026
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