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.
This is a pilot study of 120 pregnant women and their infants conducted at hospitals in the Mount Sinai Health System in New York, NY. Eighty women will deliver via elective, unlabored C-section, and 40 will undergo spontaneous vaginal delivery. The 80 women undergoing C-section will be randomized in a masked (blinded) 1:1 fashion to have their neonates undergo vaginal seeding or placebo seeding immediately after birth (within 10 minutes) followed by standard care.The infants of the 40 women undergoing spontaneous vaginal delivery will receive usual standard care. All 120 pregnant women will have biospecimens collected to assess their vaginal, skin, gut, placental, breast milk, and oral microbiome. All infants will have biospecimens collected to assess their gut, skin, nasal, and oral microbiome, as well as blood to assess allergen sensitization and immune markers. Infants will be followed with at-home stool collections and questionnaires weekly for the first 4 weeks and at weeks 8, 26, and 39. An in-person study visit will occur at 13 weeks and 52 weeks, and the primary endpoint will be assessed at 52 weeks. Study enrollment is projected to occur over 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
114
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.
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.
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
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.
Mount Sinai West
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: Infants at 12 months of age (=Month 12 visit)
Occurrence of Adverse Events (AEs) -by Treatment Group
Adverse events reported as possibly related, probably related, or definitely related to study participation.
Time frame: 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
Evaluation for the presence of aeroallergens (house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus), and/or cockroach (Blattella germanica)), in infants at 12 months of age as determined by serum IgE assessment. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen.
Time frame: Infants at 12 months of age (=Month 12 visit)
Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group
Defined by serum IgE levels. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen. The following allergen-specific IgE levels will be included: egg, milk, peanut, house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus) and cockroach (Blattella germanica).
Time frame: Infants at 12 months of age (=Month 12 visit)
Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group
Defined as the sum of the serum IgE levels to: egg, milk, peanut, house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus), and cockroach (Blattella germanica). Necessary for inclusion in this outcome measure: Available results for all six allergen-specific IgE levels.
Time frame: 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
Defined by serum IgE levels. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL.
Time frame: Infants at 12 months of age (=Month 12 visit)
Severity of Atopic Dermatitis - by Treatment Group
Severity will be measured using the Eczema Area and Severity Index (EASI), a standardized investigator-assessed instrument.
Time frame: Infants at 3 months and 12 months of age (=Month 3 and -12 visits)
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