Food Allergy in Infants Clinical Trial
— ESCAPEOfficial title:
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | September 2029 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Participant must be able to understand and provide informed consent - Parental permission must be provided for infants - Adults, 18 years and older and their child - Pregnant women in first or second trimester, carrying a fetus with a first-degree relative with any self- reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic eczema or food allergy) - Intention to breastfeed more than 3 months - Must have history of eating peanut and egg and have tolerated consumption with no food allergy reactions - Willing to be randomized to consumption or avoidance diet Exclusion Criteria: - Inability or unwillingness of a participant to give written informed consent or comply with study protocol. - Chronic infection or inflammatory disease such as cystic fibrosis or inflammatory arthritis. - Renal/liver/cardiac insufficiency. - Mothers with peanut or egg allergy. - Mothers who refuse to eat peanut (or peanut products) and/or eggs (or products containing eggs) . - Known immunodeficiency. - 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 participant's ability to comply with study requirements. - Past or current medical problems or findings from physical examination or laboratory testing 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 participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory: Peanut sensitization | The proportion of high-risk infants who have developed peanut sensitization | four months | |
Other | Exploratory: Symptoms | Symptoms of non-IgE mediated food allergy | four months | |
Other | Exploratory: Peanut sensitization | Parent-reported peanut allergy | 12 months | |
Primary | Egg sensitization | The proportion of high-risk infants who have developed egg sensitization | four months | |
Secondary | Peanut and egg specific IgG and IgG4 | Levels of infant peanut and egg specific IgG and IgG4 | four months | |
Secondary | Antibodies in maternal blood | Egg and peanut specific-IgG and IgG4 antibody concentrations in maternal blood | four months | |
Secondary | Egg allergy | Evaluate parent-reported egg allergy | 12 months | |
Secondary | Antigen concentrations | Examine human milk, house dust, egg and peanut antigen concentrations | one, two, three and four months |
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