Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06260956
Eligibility Criteria:
Inclusion Criteria:
• o Subject must be able to understand and provide informed consent.
* English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
* Maternal consent must be provided for infants.
* Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
* Self-reported at time of enrollment:
* no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester
* carrying a fetus with a first-degree relative (i.e., mother, father, full sibling) with any self-reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy).
* Intend to give their infant their own breast milk for more than 3 months.
* Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.
* Willing to be randomized to consumption or avoidance diet.
* Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.
Exclusion Criteria:
* Inability or unwillingness of subject to give written informed consent or comply with study protocol.
* Known history of renal/liver/cardiac insufficiency in the mother or infant.
* Pregnant women with PN or egg allergy.
* Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
* Physician diagnosed immunodeficiency in the mother or infant.
* 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 subject's ability to comply with study requirements.
* Past or current medical problems or findings from medical history 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 subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06260956
Study Brief:
Protocol Section:
NCT06260956