Can a swab of Mom's fluids boost C-Section Babies' microbiome?
NCT ID NCT05505110
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether it is safe and practical to swab the noses of C-section babies with maternal vaginal secretions. The goal is to see if this can modify the baby's respiratory microbiome. Twenty healthy newborns will be randomly assigned to receive either the vaginal seeding or a sterile swab. The study focuses on feasibility and safety, not yet on health outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- maternal vaginal secretions
- What this could lead to
- If successful, this could pave the way for larger studies exploring whether vaginal seeding helps restore the respiratory microbiome in C-section babies.
- What could go wrong
- This is a very early, small feasibility trial with only 20 participants. It is not designed to prove health benefits, and safety monitoring is a primary focus.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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