Recruiting

Early Phase 1

Observational StudyMOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05505110

Conditions

C-section

Vaginal Seeding

Respiratory

Microbiome

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Vaginal Seeding

Sterile Swab

Study Details

Brief 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.

Conditions

C-section

Vaginal Seeding

Respiratory

Microbiome

Study ID

NCT05505110

Start date

Nov 9, 2022

Status verified date

Nov, 2025

Completion date

Aug 10, 2028

Anticipated

Primary completion date

Aug 10, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

For the mother:

Female 18-40 years of age who is in good general health, is fully able to provide consent to participate in the study, anticipates being available for the duration of the study, and is willing to comply with all study procedures
Singleton pregnancy
Completed ≧3 prenatal care visits at Vanderbilt University Medical Center (any facility)
Having rectovaginal swabs collected at ≧36 weeks of gestation to screen for Group B Streptococcus (GBS) as part of prenatal screening tests
Having a scheduled (planned or non-emergency) C-section at Vanderbilt University Medical Center (main campus only)
No intent to relocate outside the middle Tennessee region within 12 months of recruitment

For the child:

Estimated gestational age ≧37 weeks
Birth weight ≧2,500 grams

Exclusion Criteria:

For the mother:

Past medical history of any of the following:

Previous child with GBS infection or prior positive GBS testing
Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
Genital herpes simplex virus (HSV) infection, genital herpetic lesions, or prior positive genital HSV testing
Genital human papilloma virus (HPV) infection, genital HPV lesions, or prior positive genital HPV testing
Diabetes type I or type II
Laboratory evidence during the current pregnancy of any of the following:

GBS bacteriuria in urine samples collected at any time (performed as standard of care)
GBS colonization in rectovaginal swabs collected at ≧36 weeks of gestation (performed as standard of care)
Chlamydia, trichomoniasis, or gonorrhea in urine samples collected at ≧36 weeks of gestation (performed as part of the screening procedures for this study)
Hepatitis B, hepatitis C, HIV, or syphilis in blood samples collected at ≧36 weeks of gestation (performed as part of the screening procedures for this study)
Uncontrolled gestational diabetes
Any serious obstetric disease (e.g., preeclampsia with severe features, placental abruption or severe bleeding, or thromboembolic disease) as deemed by the PI or co-investigators
Prior abnormal Pap smear
C-section scheduled for a genitourinary infection that would have interfered with vaginal delivery (e.g., genital herpetic lesions)
Lack of available prenatal screening tests
Use of systemic (i.e., oral, intramuscular, or intravenous) antibiotics in the 4 weeks prior to delivery (except for those being administered as part of the C-section)
Use of systemic (i.e., oral, intramuscular, or intravenous) immunosuppressive, biologic, or chemotherapeutic agents in the 3 months prior to delivery (except for systemic immunosuppressive agents not being used for their immunosuppressive effects \[e.g., prenatal intramuscular beclomethasone for fetal lung maturation\])
Fever (≧100.4°F \[38°C\]) in the 72 hours prior to delivery
Symptoms (e.g., dysuria, pruritus, or discharge) suggestive of a genitourinary infection (e.g., bacterial vaginosis, vaginal yeast infection, chorioamnionitis, or urinary tract infection) on the day of delivery
Symptoms (e.g., pain, tenderness, tingling, burning, itching, or swollen lymph nodes) suggestive of genital HSV infection on the day of delivery
Other symptoms (e.g., new-onset rhinorrhea, sore throat, cough, body aches, chills, nausea, vomiting, or diarrhea) suggestive of an acute infectious disease on the day of delivery
Physical exam findings (e.g., fever \[≧100.4°F (38°C)\] or vesicles, warts, or ulcers in the genital, perineal, or anal region) suggestive of a genitourinary infection on the day of delivery (performed as part of the screening procedures for this study if not performed as standard of care)
Maternal vaginal pH>4.5 on the day of delivery (performed as part of the screening procedures for this study)
Need for a switch from a scheduled C-section to an emergency C-section
Prelabor prolonged rupture of membranes (i.e., ≧18 hours prior to delivery)
Pregnancy as the result of an assisted reproductive technology or surrogacy
Participation in another clinical trial that involves an intervention that could impact the quality or interpretation of the study data as deemed by the PI or co-investigators
Other past or current medical problems that could compromise the safety of participants, interfere with their ability to comply with study requirements, or impact the quality or interpretation of the study data as deemed by the PI or co-investigators

For the child:

Need for neonatal measures outside routine clinical care (i.e., drying, tactile stimulation, bulb syringe or catheter suction of nose and mouth, or temperature maintenance) in the delivery room
Transfer to the neonatal intensive care unit immediately after delivery
Thick particulate meconium noted during delivery
Physical exam findings (e.g., tachypnea, nasal flaring, retractions, cyanosis, or grunting) suggestive of neonatal acute respiratory distress immediately after delivery (performed as part of the screening procedures for this study)
Prenatal diagnosis of a serious genetic, respiratory, cardiovascular, or neurological disease
Prenatal diagnosis of intrauterine growth restriction
Prenatal diagnosis of a major congenital anomaly (e.g., cleft lip or palate, cystic hygroma, or giant omphalocele)
Participation in another clinical trial that involves an intervention that could impact the quality or interpretation of the study data as deemed by the PI or co-investigators
Other past or current medical problems that could compromise the safety of participants, interfere with their ability to comply with study requirements, or impact the quality or interpretation of the study data as deemed by the PI or co-investigators

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Intervention Group

Vaginal Seeding

sham comparator: Control Group

Sterile Swab

Interventions

Vaginal Seeding

Following birth by C-section and immediately after the initial newborn care by the general pediatric team, children randomized to the intervention group will have their nasal cavity swabbed with maternal vaginal secretions.

Sterile Swab

Following birth by C-section and immediately after the initial newborn care by the general pediatric team, children randomized to the control group will have their nasal cavity swabbed with a sterile swab.

Primary outcome measure

Feasibility of the RCT [ Time Frame: Six months following randomization ]
Safety of the intervention [ Time Frame: Six months following randomization ]

Central Contacts and Locations

Central contacts

MOTHER SEED Study Team

615-936-5552 motherseed@vumc.org

Andrea E Lee, MA, MLS

615-936-5552 andrea.e.lee@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Andrea E Lee

615-936-5552 motherseed@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

C-section
Vaginal seeding
Respiratory
Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-11-10.