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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06260956
Other study ID # U01-ROC-001
Secondary ID 1U01AI173032
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date September 2029

Study information

Verified date February 2024
Source University of Rochester
Contact Allison W Leadley, MPH
Phone 585-275-4640
Email allison_leadley@urmc.rochester.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 400 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 (or four) 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Avoidance
Subjects avoid eating peanut and egg during pregnancy and lactation.
Consumption
Subjects consume peanut and egg during pregnancy and lactation.

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

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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