MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vaginal Seeding
  • Sterile Swab

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator