MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing

NCT05505110 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 220799K23HL148638
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

C-section; Vaginal seeding; Respiratory; Microbiome

Outcome Measures

Primary Outcomes (2)

• 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.

  Six months following randomization

• 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

  Six months following randomization

Secondary Outcomes (3)

• Timing of the intervention

  Immediately following administration of the intervention

• Proportion of in-person study visits completed

  Six months following randomization

• Common microbial ecology metrics of the maternal vaginal microbiome and of the early-life URT microbiome

  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)

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Vaginal Seeding

Biological: Vaginal Seeding

Control Group

SHAM COMPARATOR

Sterile Swab

Other: Sterile Swab

Interventions

Vaginal Seeding 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.

Intervention Group

Sterile Swab 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Study Officials

• Christian Rosas-Salazar, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOTHER SEED Study Team

CONTACT

615-936-5552; motherseed@vumc.org

Andrea E Lee, MA, MLS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the principal investigator (PI), co-investigators, data manager, and the lead biostatistician will be blinded to the actual group assignment until all statistical analyses of the data required to meet the primary and co-primary endpoints have occurred. The Data and Safety Monitoring Board will remain unmasked to actual group allocation throughout the pre-specified blinding period.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: This is a single-center, parallel-arm, blind, sham-controlled, feasibility RCT to be conducted in healthy cesarean-born children.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): August 10, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified next-generation sequencing data generated as part of this study will be deposited into NIH-sponsored or other scientific repositories immediately following a publication. Other de-identified IPD that underlie the results reported in a manuscript will be shared with other parties upon request beginning 12 months and ending 36 months following a publication. In addition, the study protocol and informed consent documents will be uploaded to clinicaltrials.gov no later than 60 days after the end-of-study visit of the last enrolled participant.
• Access Criteria: Individual requests for de-identified IPD sharing from other parties will be evaluated and approved by the PI. For this, the requesting party will need to provide a methodologically sound proposal, obtain approval from their Institutional Review Board, and sing a data sharing agreement. De-identified IPD will be mainly shared for the purpose of conducting a systematic review with meta-analysis, but other studies will be evaluated on a case-by-case basis.

Locations

US (1)