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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 40 Years
Gender	Female

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06260956
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Rochester
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy and Immunology, Peanut and Nut Allergy, Egg Allergy, Food Allergy in Infants, Food Allergy Peanut

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Arm 1 Avoidance

Subjects must avoid eating peanuts and peanut products and egg and egg products.

Active Comparator: Arm 2 Consumption

Subjects must consume peanuts and peanut products and egg and egg products.

Interventions

Behavioral: - Avoidance

Subjects avoid eating peanut and egg during pregnancy and lactation.

Behavioral: - Consumption

Subjects consume peanut and egg during pregnancy and lactation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester, Rochester, New York

Status

Address

University of Rochester

Rochester, New York, 14642

Site Contact

allison_leadley@urmc.rochester.edu

585-275-4640

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