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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vaginal Seeding
Biological/VaccineFollowing 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
Other interventionFollowing 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the RCT
The study will be considered "definitively feasible as proposed," "possibly feasible as proposed," or "not feasible as proposed" based on eligibility, consent, enrollment, and loss to follow-up rates, which could be used as preliminary data to inform the design of a future phase II RCT. For this study, "enrolled" will be defined as consented and screened, with eligibility verified, and the eligibility, consent, enrollment, and loss to follow-up rates will be calculated using the following formulas: 1) eligibility rate = number of participants who are eligible\*100 / number of participants pre-screened, 2) consent rate = number of participants who provide consent\*100 / number of participants who are eligible, 3) enrollment rate = number of participants who are enrolled\*100 / number of participants consented and who complete screening procedures, and 4) loss to follow-up = number of participants who did not complete the end-of-study visit\*100 rate / number of participants randomized.
Time frame
Six months following randomization2
Safety of the intervention
To be determined by the number of adverse events, serious adverse events, and unanticipated problems throughout the study, as defined using the standards set forth in the National Cancer Institute's - Common Terminology Criteria (NCI-CTCAE) for AEs version 4.0 and the United States Department of Health and Human Services - Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: Office for Human Research Protections Guidance 2007
Time frame
Six months following randomizationSecondary outcomes
1
Timing of the intervention
The number of minutes after birth when the intervention is performed.
Time frame
Immediately following administration of the intervention2
Proportion of in-person study visits completed
The total number of in-person study visits completed by all participants\*100 / total number of in-person visits expected for all participants for each study time point.
Time frame
Six months following randomization3
Common microbial ecology metrics of the maternal vaginal microbiome and of the early-life URT microbiome
The comparisons of the maternal vaginal microbiome on the day of delivery between study groups will be conducted using alpha-diversity (e.g., observed taxa, Shannon index, and Simpson indices), beta-diversity (e.g., Bray-Curtis, Jaccard, weighted UniFrac, and unweighted UniFrac indices), and differential abundance (at the amplicon sequence variant, genus, and/or family level) analyses. The early-life URT microbiome at each time point and over time will be compared between study groups using similar microbial ecology metrics. In pre-specified analyses, we will also compare the presence and abundance of the genus Lactobacillus and the predominant Lactobacillus amplicon sequence variants in the URT of children at each time point and over time between study groups, as this is the predominant taxa of the maternal vaginal microbiome during pregnancy.
Time frame
At each study time point (birth, ~2 days, ~5 days, ~4 weeks, and ~6 months of age) and over time (longitudinally from birth to age 6 months)Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov