Maternal Diet for Preventing Food Allergies

(ESCAPE Trial)

Overseen By Elizabeth Shade-Wenger, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Immunosuppressants

Disqualifiers: Renal/liver/cardiac insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: approximately 5 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have chronic inflammatory conditions requiring long-term systemic immunosuppressive medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment Avoidance, Consumption for preventing food allergies?

Research suggests that avoiding certain allergenic foods during pregnancy and lactation, combined with delayed introduction of these foods to infants, can reduce the risk of food allergies in children, especially those with a family history of allergies. Additionally, increased maternal intake of cow's milk during lactation has been associated with a lower prevalence of food allergies in offspring. ^{1 2 3 4 5}

Is it safe for mothers to change their diet to prevent food allergies in their children?

Current research suggests that pregnant and breastfeeding women do not need to avoid potential food allergens unless they are allergic themselves. However, dietary restrictions during lactation may have nutritional consequences, so supervision by a dietician is recommended. ^{2 4 5 6 7}

How does the treatment of maternal diet avoidance and consumption differ from other treatments for preventing food allergies?

This treatment is unique because it focuses on the maternal diet during pregnancy and breastfeeding, recommending against the exclusion of food allergens and instead considering the active introduction of certain allergens like peanuts and eggs into the infant's diet early on. Unlike other approaches that suggest avoiding allergens, this method emphasizes early exposure to potentially prevent allergies. ^{5 8 9 10 11}

Eligibility Criteria

This study is for expecting mothers who are not allergic to peanuts or eggs. It's designed to see if eating or avoiding these foods during pregnancy and breastfeeding affects their baby's risk of developing food allergies.

Inclusion Criteria

Participant must be able to understand and provide informed consent

Must have history of eating peanut and egg and have tolerated consumption with no food allergy reactions

My infant's participation has parental consent.

Exclusion Criteria

I have a long-term infection or condition like cystic fibrosis or arthritis.

My kidneys, liver, or heart are not working properly.

Mothers who refuse to eat peanut (or peanut products) and/or eggs (or products containing eggs)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Maternal diet is controlled from 27 weeks gestation through the baby's fourth month, with some consuming and some avoiding peanuts and eggs

approximately 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of peanut and egg sensitization

8 months

Treatment Details

Interventions

• Avoidance
• Consumption

Trial Overview The trial is testing the impact of maternal diet on infant allergy development. Specifically, it looks at whether mothers consuming or avoiding peanuts and eggs can influence their child's likelihood of having a peanut or egg allergy.

Participant Groups

Group I: Arm 1 Consumption Active Control 1 Intervention

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

Group II: Arm 2 Avoidance Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of combined maternal and infant food-allergen avoidance on development of atopy in early infancy: a randomized study. [2022]

2. Thailand pubmed.ncbi.nlm.nih.gov

Prevention of food allergy in the real life. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal Intake of Cow's Milk during Lactation Is Associated with Lower Prevalence of Food Allergy in Offspring. [2021]

4. Norway pubmed.ncbi.nlm.nih.gov

Parent-reported food allergy requiring an avoidance diet in children starting elementary school. [2015]

5. Denmark pubmed.ncbi.nlm.nih.gov

Food allergen avoidance in primary prevention of food allergy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Maternal consumption of dairy products, calcium, and vitamin D during pregnancy and infantile allergic disorders. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Nutrition in early life and the risk of asthma and allergic disease. [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Food allergy prevention: Where are we in 2023? [2023]

9. England pubmed.ncbi.nlm.nih.gov

Role of maternal elimination diets and human milk IgA in the development of cow's milk allergy in the infants. [2022]

10. Greece pubmed.ncbi.nlm.nih.gov

Dietary interventions for primary allergy prevention in infants. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Nutritional Issues in Food Allergy. [2020]