RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.

Official Title

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

Quick Facts

Study Start:2025-06-30

Study Completion:2029-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06260956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Allison W Leadley, MPH

CONTACT

585-275-4640

allison_leadley@urmc.rochester.edu

Leanna Twohig, MS

CONTACT

585-275-4640

Leanna_Twohig@urmc.rochester.edu

Study Locations (Sites)

University of Rochester

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30

Study Completion Date2029-09

Study Record Updates

Study Start Date2025-06-30

Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

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