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

Food Allergy in Infants Clinical Trial

— ESCAPE  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

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

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