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Official title Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
ClinicalTrials.gov ID: NCT06260956
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- o Subject must be able to understand and provide informed consent.
- Mothers will be English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish...
- 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:
You likely can't join if
- 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...
See the full eligibility criteria
- o Subject must be able to understand and provide informed consent.
- Mothers will be 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...
- 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 assigned by chance to consumption or avoidance diet.
- Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment. Infants will be minimum age, 1 day (birth), through 365 days (12 months).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 1 day and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.