C-sectionEarly Phase 1MOTHER SEEDNCT05505110
MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
A Early Phase 1 study testing Vaginal Seeding and Sterile Swab in people with C-section and Vaginal Seeding, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- C-section, Vaginal Seeding, Respiratory
- What is being tested?
- Vaginal Seeding and Sterile Swab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 10 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 40Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Andrea E Lee, 615-936-5552, motherseed@vumc.org
About this study
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.
Read the 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
- Being tested
- Vaginal Seeding, Sterile Swab
- Keywords
- C-section, Vaginal seeding, Respiratory, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal SeedingBiological
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.
Sterile SwabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Vaginal Seeding Receives: Biological: Vaginal Seeding |
| Control Group | Sham comparator | Sterile Swab Receives: Other: Sterile Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Six months following randomization
Secondary outcomes (3)
Timing of the intervention
The number of minutes after birth when the intervention is performed.
Measured: Immediately following administration of the intervention
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.
Measured: Six months following randomization
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start9 Nov 2022
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-sectionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, parallel-arm, blind, sham-controlled, feasibility RCT to be conducted in healthy cesarean-born children.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christian Rosas-Salazar, Vanderbilt University Medical Center
- Investigators
- Christian Rosas-Salazar, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505110
- Sponsor's protocol ID
- 220799
- Other IDs
- K23HL148638
- Acronym
- MOTHER SEED
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 individual participant data (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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
- ClinicalTrials.gov ID
- NCT05505110
- Acronym / sponsor ID
- MOTHER SEED / 220799
- Conditions
- C-section, Vaginal Seeding, Respiratory, Microbiome
- Keywords
- C-section, Vaginal seeding, Respiratory, Microbiome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, parallel-arm, blind, sham-controlled, feasibility RCT to be conducted in healthy cesarean-born children.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Biological: Vaginal SeedingVaginal Seeding |
| Control Group | Sham comparator | Other: Sterile SwabSterile Swab |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (40 listed)
- Past medical history of any of the following:
- Laboratory evidence during the current pregnancy of any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal SeedingFollowing 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. | Biological | Intervention Group |
| Sterile SwabFollowing 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. | Other | Control Group |
Primary outcome
Feasibility of the RCT
Time frame: Six months following randomization
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.
Safety of the intervention
Time frame: Six months following randomization
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
3 secondary outcomes
Timing of the intervention
Time frame: Immediately following administration of the intervention
Proportion of in-person study visits completed
Time frame: Six months following randomization
Common microbial ecology metrics of the maternal vaginal microbiome and of the early-life URT microbiome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: Yes. 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 individual participant data (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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Rosas-Salazar, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vaginal Seeding and Sterile Swab in people with C-section and Vaginal Seeding, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MOTHER SEED Study Team (615-936-5552, motherseed@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the RCT (time frame: Six months following randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.