Maternal peanut and egg consumption versus avoidance during pregnancy and breastfeeding

Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg

This study will test whether mothers eating or avoiding peanuts and eggs from late pregnancy through breastfeeding changes babies' chances of developing peanut or egg allergies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: University of Rochester (Academic / other)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT06260956 on ClinicalTrials.gov

What this trial studies

This is a randomized, single-blind, parallel two-arm trial that will assign about 500 pregnant women to either consume or avoid peanuts and eggs from 27 weeks gestation through their baby's fourth month. Participants are mother/infant dyads planning to exclusively breastfeed, with roughly 25% recruited locally at the University of Rochester and the remainder enrolled nationally. The study will measure infant sensitization to peanut and egg and collect biological samples to explore mechanisms of tolerance or sensitization. Randomization is one-to-one and the protocol combines dietary guidance with scheduled follow-up assessments in early infancy.

Who should consider this trial

Good fit: Pregnant women aged 18 or older who can consent, intend to exclusively breastfeed for at least three months, and are willing to follow assigned dietary guidance about peanuts and eggs from 27 weeks gestation through four months postpartum.

Not a fit: Infants who are not exclusively breastfed, mothers unable or unwilling to adhere to the assigned diet, or those with conditions requiring systemic immunosuppression are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the results could inform clearer dietary guidance for pregnant and breastfeeding women to reduce infants' risk of peanut and egg sensitization.

How similar studies have performed: Previous randomized infant-introduction trials (for example LEAP) have shown benefit from early introduction of peanut to infants, but randomized trials of maternal consumption versus avoidance are limited, so this maternal-diet approach is relatively novel and unproven.

Eligibility criteria

Inclusion Criteria:

• o Subject must be able to understand and provide informed consent.

* English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
* Maternal consent must be provided for infants.
* Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
* Self-reported at time of enrollment:

  * no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester
  * carrying a fetus with a first-degree relative (i.e., mother, father, full sibling) with any self-reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy).
* Intend to give their infant their own breast milk for more than 3 months.
* Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.
* Willing to be randomized to consumption or avoidance diet.
* Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.

Exclusion Criteria:

* Inability or unwillingness of subject to give written informed consent or comply with study protocol.
* Known history of renal/liver/cardiac insufficiency in the mother or infant.
* Pregnant women with PN or egg allergy.
* Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
* Physician diagnosed immunodeficiency in the mother or infant.
* Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
* Past or current medical problems or findings from medical history that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Where this trial is running

Rochester, New York

• University of Rochester — Rochester, New York, United States (Recruiting)

Study contacts

• Study coordinator: Allison W Leadley, MPH

Conditions Allergy and Immunology; Peanut and Nut Allergy; Egg Allergy; Food Allergy in Infants; Food Allergy Peanut