NIH-funded research U01 cooperative agreement

Preventing food allergies by protecting babies' skin

Official title: SEAL (Stopping Atopic dermatitis and ALlergy) Study: Prevent allergy by enhancing the skin barrier

Funded at Harvard University D/b/a Harvard School of Public Health · NIH-11393205 · Data updated 2026-11-12

This trial tests whether starting a trilipid moisturizer plus early gentle topical steroids for babies with dry skin or early eczema can lower their chance of developing food allergies.

More Atopic Dermatitis research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionHarvard University D/b/a Harvard School of Public Health
NIH-funded
Lab location1 site (Boston, United States)
Project startAugust 14, 2020
Project endMay 31, 2027
Funding year2025
Award (this year)$205,350
NIH project number3U01AI147462-06S2
Project IDNIH-11393205 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are infants who show dry skin or the earliest signs of eczema within the first 10 weeks of life and who do not yet have diagnosed food allergies.

Less likely to help

Children who already have confirmed food allergies or older children beyond the newborn period are unlikely to gain preventive benefit from this intervention.

What this research studies

If your baby develops dry skin or early eczema in the first weeks of life, this study would enroll them and start skin-focused treatment right away. Babies are randomly assigned to receive proactive care with a trilipid emollient and early topical steroid use versus a reactive approach when symptoms worsen. The trial plans to enroll about 750 infants and will follow them to see whether reducing skin problems prevents later food allergy. Doctors will monitor skin severity, any allergic sensitization, and food allergy outcomes over time through clinic visits and testing.

Why it matters

Potential benefit: If successful, this approach could lower the number of children who develop food allergies by preventing allergen sensitization through damaged skin.

How similar studies have gone: Prior trials like LEAP and EAT showed early feeding can prevent peanut allergy and smaller studies suggest improving the skin barrier may reduce sensitization, but large randomized trials using proactive skin barrier treatment for allergy prevention are still limited.

Where this research is happening

  • Harvard University D/b/a Harvard School of Public Health
    Boston, United States
    Active

Researchers

  • Principal investigator: Nadeau, Kari C. — Harvard University D/b/a Harvard School of Public Health
  • Study coordinator: Nadeau, Kari C.

Related research

Other NIH-funded projects on the same topics.

  • Stopping Atopic Dermatitis and Allergy: Preventing Food Allergy by Protecting the Skin

    A large study in infants at high risk for allergies tests whether using a skin barrier cream together with early, proactive skin care can prevent peanut allergy and other food allergies.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11532535

  • SEAL Study: Preventing peanut allergy by protecting baby skin

    This trial tests whether using a skin-emollient and proactive skin steroids early in life can prevent peanut allergy in high-risk infants.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11532533

  • SEAL Study: Prevent allergy by protecting the baby’s skin

    A very young group of high-risk babies will try a early skin-care plan to reduce eczema and prevent peanut allergy.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11516452

  • Preventing eczema-related allergies by strengthening infants' skin barrier

    This project will see if using a trilipid skin cream plus proactive mild topical steroids in infants with early dry skin or eczema lowers their chances of developing food allergies.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11418544

  • SEAL: Stopping eczema and allergy by protecting the skin in infants

    A large clinical study in early infancy tests whether using a skin barrier cream together with a gentle anti-inflammatory cream can reduce the chance of developing food allergies.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11406152

  • Preventing food allergy by strengthening babies' skin barrier

    See if giving a trilipid emollient plus proactive topical steroid treatment to infants with very early dry skin or eczema can lower their chance of developing food allergies.

    NIH research Harvard University D/b/a Harvard School of Public Health · Boston, United States · NIH-11392091

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.