Hugh Sampson, MD | Icahn School of Medicine at Mount Sinai | New York

Jose Clemente, PhD | Icahn Institute for Genomics and Multiscale Biology | New York

Mount Sinai Hospital | New York, NY

Mount Sinai West | New York, NY

ACTIVATE is a pilot study that will investigate how differences in the microbiome of a baby may protect, or put them at risk, for allergies. The study will measure whether wiping babies born by C-section with their mother’s vaginal fluids (which contains potentially beneficial bacteria; referred to as “vaginal seeding”) right after birth will lower the risk of developing positive allergy tests at one year of age.

ACTIVATE will enroll 120 pregnant women and their babies who are at higher-risk for developing allergies. This will include:

• 80 women who are planning a C-section delivery who will be randomized 1:1 to have their newborns undergo vaginal seeding with vaginal microbiota or placebo seeding within 5 minutes after birth

• 40 women who are planning a vaginal delivery

Vaginal seeding has not been approved by the FDA and, therefore, is considered an experimental procedure in this study. As part of this study we will be assessing the safety of vaginal seeding, as well as whether it can help protect babies from developing egg, milk, and peanut allergies at 12 months of age.

You may be eligible to participate in the ACTIVATE study if you are:

• 18 to 45 years of age
• In your second or third trimester of pregnancy
• Planning an elective (scheduled) C-section or a vaginal delivery
• Your expected baby has a mother, biological father, or full brother or sister who have allergic disease such as hay fever, food allergy, asthma, or atopic dermatitis