An interventional study of Consumption and Avoidance in Allergy and Immunology, Peanut and Nut Allergy and Egg Allergy, sponsored by University of Rochester. Recruiting at 1 site in United States. Open to female participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Rochester · Not applicable, Interventional, and Prevention
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.
The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 500 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Self-reported at time of enrollment:
Infants will be minimum age, 1 day (birth), through 365 days (12 months).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects must consume peanuts and peanut products and egg and egg products.
Behavioral: Consumption
Subjects must avoid eating peanuts and peanut products and egg and egg products.
Behavioral: Avoidance
Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
Egg or peanut sensitization
Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).
Time frame: four months
Peanut and egg specific IgG and IgG4
Levels of infant peanut and egg specific IgG and IgG4
Time frame: four months
Antibodies in maternal blood
Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.
Time frame: four months
Egg allergy
Questionnaire for parents to report any signs of egg allergy in their child.
Time frame: 12 months
Egg and peanut specific IgE
Measure levels of infant egg- and peanut-specific IgE.
Time frame: four months
Exploratory: Peanut sensitization
The proportion of high-risk infants who have developed peanut sensitization
Time frame: four months
Exploratory: Egg sensitization
Proportion of infants who develop egg sensitization.
Time frame: four months
Exploratory: Symptoms
Questionnaire for parents to report symptoms of non-IgE mediated food allergy
Time frame: four months
Exploratory: Peanut sensitization 12 months
Questionnaire for parents to report signs of peanut allergy
Time frame: 12 months
Mechanistic: antigen level
Measure PN and egg antigen levels in house dust and human milk
Time frame: four months
Mechanistic: IgG levels
Quantify PN- and egg-specific IgG antibody levels in maternal serum and human milk.
Time frame: four months
Mechanistic: T cell
Phenotype infant T cell populations in cord blood and infant blood.
Time frame: four months
Plan to share: Yes — Per NIH policy
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2028, 34 months after the start.
Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 34 months is above that.
Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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