Educational Support for Food Allergy Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether providing educational materials alone or with additional in-person support can help parents introduce potentially allergenic foods to their infants early. The goal is to guide doctors in supporting new parents to prevent food allergies. One group of participants will receive educational materials, while another group will receive the same materials plus in-person teaching and feeding sessions. The trial seeks infants born full-term who have not yet started eating the top allergenic foods and do not have severe eczema or confirmed food allergies. As an unphased trial, this study offers parents a unique opportunity to contribute to important research that could shape future guidelines for preventing food allergies in infants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on infants and their feeding habits, so it's best to consult with the trial coordinators for specific guidance.
What prior data suggests that this educational support method is safe for early food allergen introduction?
Research has shown that introducing allergenic foods early and maintaining them in a child's diet might be safe. One study found that giving children a mix of these foods early can help prevent food allergies. Another study demonstrated that starting foods like oats and fish early could reduce the risk of asthma and nasal allergies. Experts support these early introduction strategies to lower food allergy risks in children. So far, these methods appear well-tolerated, with no major safety concerns reported.12345
Why are researchers excited about this trial?
Researchers are excited about the Educational Support for Food Allergy Prevention trial because it explores innovative ways to prevent food allergies through early introduction and sustained ingestion (EISI) of allergens. Unlike traditional methods that might delay introducing allergenic foods, this trial emphasizes early exposure, potentially reducing the risk of developing food allergies. The trial also provides enhanced educational opportunities, offering in-person teaching sessions and in-clinic feedings, which allow participants to learn and experience safe exposure under professional guidance. This proactive approach could revolutionize how we manage and prevent food allergies, making it a game-changer in allergy prevention strategies.
What evidence suggests that this trial's educational support methods could be effective for food allergy prevention?
Research has shown that introducing allergenic foods early and continuing regular consumption can reduce the risk of food allergies in children. Studies like LEAP and EAT found that consuming at least 2 grams of these foods weekly can significantly lower allergy risks. This trial will compare two approaches: the Standard of Care, where participants receive educational materials about early introduction, and the Enhanced Educational Opportunities arm, which includes additional teaching sessions and in-clinic feedings. The goal is to help the immune system adapt to these foods early on, reducing the impact of food allergies. Overall, starting early and regularly consuming allergenic foods appears to be an effective way to prevent allergies.35678
Who Is on the Research Team?
Sharon Chinthrajah, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for parents or caregivers over 18 with infants born at term (37-41 weeks gestation), regardless of family history of allergies or presence of mild to moderate eczema. Infants must not have started consuming T9 foods, except cow's milk/soy in formula, and agree to two blood draws during the 6-month study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive educational materials and, for the intervention group, additional in-person or live-stream video support and in-clinic feedings
Follow-up
Participants are monitored for allergenic food intake and questionnaire completion
What Are the Treatments Tested in This Trial?
Interventions
- Early Introduction and Sustained Ingestion (EISI)
Trial Overview
The trial examines if educational materials alone or combined with in-person support can increase early feeding of allergy-risk foods. It aims to inform pediatricians and allergists on supporting new parents in preventing food allergies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The participants will be provided with three sets of educational materials to learn about early introduction of food allergens, as well as 3 in-person monthly teaching sessions (up to 3 months), lasting 30 minutes to enhance the information and allow for questions. This arm will also have one to two in-clinic feedings of any of the top 9 most allergenic foods. The oral feeding portion will add an additional 1 to 2 hours at the one of the 3 visits.
The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Citations
Early Introduction of Allergenic Foods and the Prevention ...
The early introduction of allergenic foods appears to be an effective strategy for minimizing the public health burden of food allergy, though ...
2.
publications.aap.org
publications.aap.org/pediatrics/article/156/5/e2024070516/204636/Guidelines-for-Early-Food-Introduction-andGuidelines for Early Food Introduction and Patterns of Food ...
In survey-based studies, 29% of general pediatricians10 and 65% of allergists11 endorsed full implementation of the 2017 early peanut ...
Health Promotion of Early and Sustained Allergenic Food ...
This clinical management review provides an overview on the data that informs early and sustained allergenic food introduction strategies, suggestions on how to ...
Study Details | NCT06262867 | Early Allergen System ...
The data from LEAP and EAT indicate that ingestion of 2 grams of protein per week of the allergenic food was required to decrease the risk of food allergy.
5.
allergenbureau.net
allergenbureau.net/advances-in-reducing-food-allergy-risk-through-early-introduction/Advances In Reducing Food Allergy Risk Through Early ...
Experts are delving further into the impact of early introduction strategies on childhood food allergies, with several initiatives currently underway.
Early Introduction and Sustained Ingestion (EISI) Using ...
The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone ...
Prevention of Food Allergy: The Significance of Early ...
Early introduction of oats associated with decreased risk of persistent asthma and early introduction of fish with decreased risk of allergic rhinitis. Br ...
Early Introduction of Multi-Allergen Mixture for Prevention ...
The results of this study suggest that the early introduction of foods, particularly simultaneous mixtures of many allergenic foods, may be safe and efficacious ...
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