Maternal peanut and egg consumption versus avoidance during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Mothers will be 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.

Infants will be minimum age, 1 day (birth), through 365 days (12 months).

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 it's running

• University of Rochester
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Allison W Leadley, MPH
• Email: allison_leadley@urmc.rochester.edu
• Phone: 585-275-4640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.