MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

NCT ID: NCT05505110

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2028-08-10

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.

Detailed Description

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 procedure will be performed following birth by C-section and immediately after the initial newborn care by the general pediatric team. The mother and child will then receive usual medical care as determined by their health care providers. Follow-up will occur at multiple time points during the child's first 6 months of life. One planned interim analysis to assess the safety of the procedure will be conducted.

The intervention aims to transfer the maternal vaginal microbiome to the nasal cavity of cesarean-born children at birth (i.e., vaginal seeding of the URT). Hence, the intervention simply attempts to replicate the natural exposure to maternal vaginal secretions during vaginal delivery in children born by C-section.

Conditions

C-section; Vaginal Seeding; Respiratory; Microbiome

Keywords

C-section; Vaginal seeding; Respiratory; Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

Vaginal Seeding

Group Type: ACTIVE_COMPARATOR

Vaginal Seeding

Intervention Type: BIOLOGICAL

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.

Control Group

Sterile Swab

Group Type: SHAM_COMPARATOR

Sterile Swab

Intervention Type: OTHER

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.

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christian Rosas-Salazar

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Rosas-Salazar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

MOTHER SEED Study Team

Role: CONTACT

Phone: 615-936-5552

Email: motherseed@vumc.org

Andrea E Lee, MA, MLS

Role: CONTACT

Phone: 615-936-5552

Email: andrea.e.lee@vumc.org

Facility Contacts

Andrea E Lee

Role: primary

Other Identifiers

K23HL148638

Identifier Type: NIH

Identifier Source: secondary_id

View Link

220799

Identifier Type: -

Identifier Source: org_study_id