Vaginal Microbiome Exposure and Immune Responses in C-section Infants

NCT03567707 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: DAIT ITN079ADACTIVATE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma. Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.

Conditions

Allergic Diseases; Asthma

Keywords

Vaginal seeding; Immune responses; Allergen sensitization

Outcome Measures

Primary Outcomes (1)

• Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group

  Evaluation for the presence of food allergens (egg, milk, and peanut) in infants at 12 months of age. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen.

  Infants at 12 months of age (=Month 12 visit)

Secondary Outcomes (6)

• Occurrence of Adverse Events (AEs) -by Treatment Group

  From birth to 12 months of age (=Month 12 visit)

• Presence of Sensitization to at Least One Aeroallergen at 12 months of age - by Treatment Group

  Infants at 12 months of age (=Month 12 visit)

• Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group

  Infants at 12 months of age (=Month 12 visit)

• Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group

  Infants at 12 months of age (=Month 12 visit)

• Number of Food Allergens and Aeroallergens Each Infant is Sensitized to at 12 Months of Age-by Treatment Group

  Infants at 12 months of age (=Month 12 visit)

Other Outcomes (9)

• EXPLORATORY: Comparison by Treatment Group in Bacterial Composition of the Infant Microbiome

  Infants at 12 months of age (=Month 12 visit)

• EXPLORATORY: Comparison by Treatment Group in Fungal Composition of the Infant Microbiome

  Infants at 12 months of age (=Month 12 visit)

• EXPLORATORY: Comparison by Treatment Group in T Cell Profiles

  Infants at 12 months of age (=Month 12 visit)

Study Arms (3)

C-section -Vaginal seeding

EXPERIMENTAL

Pregnant women who undergo C-section and (neonate) vaginal seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery.

Drug: Vaginal seeding; Other: Standard care; Other: Post-seeding Care

C-section - Placebo Seeding

EXPERIMENTAL

Pregnant women who undergo C-section and (neonate) placebo seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo).

Drug: Placebo Seeding; Other: Standard care; Other: Post-seeding Care

Vaginal Delivery

ACTIVE COMPARATOR

Pregnant women who undergo spontaneous vaginal delivery (of neonate).

Other: Standard care

Interventions

Vaginal seeding DRUG

Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Also known as: vaginal microbiota, maternal vaginal microbiota

C-section -Vaginal seeding

Placebo Seeding DRUG

Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Also known as: placebo microbiota, placebo vaginal microbiota

C-section - Placebo Seeding

Standard care OTHER

Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery

Also known as: standard of care

C-section - Placebo Seeding; C-section -Vaginal seeding; Vaginal Delivery

Post-seeding Care OTHER

Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.

C-section - Placebo Seeding; C-section -Vaginal seeding

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman must be able to understand and provide informed consent;
• Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and

You may not qualify if:

• For C-Section Mothers:
• In labor with evidence of cervical change prior to the scheduled C-section;
• Rupture of the amniotic sac; or
• Vaginal pH \> 4.5 on the day of delivery.
• For Vaginal Delivery Mothers:
• \- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter).
• For All Mothers and Their Infants:
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
• History of moderate to severe atopic dermatitis within the past year in the mother;
• Express no intention to breastfeed;
• History of diabetes mellitus or gestational diabetes mellitus;
• History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis);
• Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery;
• Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus;
• Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative;

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• PPD Development, LP: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (2)

Mount Sinai West

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Links

• ITN website for trial
• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Immune Tolerance Network (ITN)

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hugh A. Sampson, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Jose C. Clemente, PhD

  Icahn Institute for Genomics & Multiscale Biology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: With the exception of the study nurse performing the vaginal seeding procedure, all study participants and study personnel will be masked (blinded) to the infant's randomization status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: This study will enroll pregnant women during the third trimester of pregnancy whose infants have a first-degree relative ( the mother, biological father, or full sibling) with atopic disease or food allergy.The study excludes women with a history of active atopic dermatitis within the past 5 years to avoid the potential transfer of vaginal microbiota to the infant that may predispose to atopic disease.Women undergoing elective, unlabored C-section will be randomized to have their infants undergo vaginal seeding or placebo seeding plus standard of care. Women and infants who undergo placebo seeding will serve as a control population.In addition, women and infants undergoing vaginal delivery will also be included as a second control group, in part to determine if vaginal seeding will decrease allergen sensitization rates to a level similar to vaginally delivered infants, and also to serve as a comparator group for gut microbiome development during the infant's first year of life.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: November 28, 2018
• Primary Completion: January 30, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The aim is to share data available to the public within 24 months upon completion of the study.
• Access Criteria: ImmPort public data access.

Locations

US (2)