500 Participants Needed

Maternal Diet for Preventing Food Allergies

(ESCAPE Trial)

AW
JL
LT
ES
Overseen ByElizabeth Shade-Wenger, BS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if eating or avoiding peanuts and eggs during pregnancy and breastfeeding affects infants' development of allergies to these foods. Participants will join one of two groups: one will consume peanuts and eggs, while the other will avoid them. Healthy pregnant women who plan to breastfeed, have no food allergies, and have a family history of allergies may be suitable candidates. The goal is to see if maternal diet can help prevent food allergies in babies. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could shape future dietary recommendations for expectant mothers.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pregnant and breastfeeding mothers can generally eat peanuts and eggs safely. Studies suggest that consuming small amounts, such as less than 5 grams of peanuts per week, might even help protect babies from developing peanut allergies. One large study involving nearly 14,000 children found no connection between mothers eating peanuts and their children having peanut allergies.

Conversely, avoiding peanuts and eggs does not seem to pose any safety issues. However, some research indicates that eating these foods earlier might reduce the risk of allergies in babies. Overall, both choices appear safe for mothers and their babies, but eating peanuts and eggs might offer extra protection against allergies.12345

Why are researchers excited about this trial?

Researchers are excited about the Maternal Diet for Preventing Food Allergies trial because it's exploring two different dietary approaches that could potentially reduce the risk of food allergies in infants. Unlike typical allergy treatments, which often focus on managing symptoms after they occur, this trial is about prevention from the start. The Consumption arm is unique because it involves mothers consuming peanuts and eggs during pregnancy and breastfeeding, which might help prevent allergies in their children by promoting early tolerance. On the other hand, the Avoidance arm investigates whether steering clear of these foods altogether can yield similar preventive benefits. This trial could reshape our understanding of allergy prevention, offering new insights into how maternal diet can influence a child's allergy risk.

What evidence suggests that this trial's treatments could be effective for preventing food allergies?

This trial will compare two approaches: consuming and avoiding peanuts and eggs during pregnancy. Research has shown that when pregnant women eat peanuts and eggs, it might help lower the risk of their babies developing food allergies. One study found that children whose mothers ate more peanuts and tree nuts had fewer peanut allergies. Guidelines also suggest that introducing these foods early to infants can reduce allergy rates. Conversely, little evidence supports the idea that avoiding peanuts and eggs during pregnancy prevents allergies in babies. Most studies focus on the benefits of consuming these foods rather than avoiding them. Thus, current research suggests that eating peanuts and eggs during pregnancy might help reduce allergy risks.16789

Are You a Good Fit for This Trial?

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.
See 4 more

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)
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Arm 1 ConsumptionActive Control1 Intervention
Group II: Arm 2 AvoidanceActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Study to test if mothers' diet prevents early sign of food ...The new clinical trial aims to clearly determine the efficacy of including peanuts and eggs in expecting mothers' diets before and after birth ...
Guidelines for Early Food Introduction and Patterns of Food ...The prevalence of clinician-diagnosed peanut and overall IgE-mediated food allergy in infants decreased following the publication of early ...
Can Maternal Peanut, Egg Consumption Prevent Food ...Can Maternal Peanut, Egg Consumption Prevent Food Allergies in Babies? An NIH trial will assess whether eating peanuts and eggs during pregnancy and ...
Introduction of egg, peanut and tree nuts into infant food in ...In France, about 6% of children are affected, with cow's milk, egg, peanut and tree nuts among the most frequent causal allergens [3]. Food ...
Study Details | NCT06262867 | Early Allergen System ...The Learning Early About Peanut (LEAP) study demonstrated a significant reduction in peanut allergy by introducing peanuts early, irrespective of baseline ...
Infant Diet Recommendations Reduce IgE-Mediated Egg, ...Meta-analyses of randomized controlled trials have found that introducing eggs and peanuts earlier during infancy reduced egg and peanut allergy risk.
The protective effect of moderate maternal peanut ...Moderate consumption (<5 grams per week) of peanuts while breastfeeding provides a significant protective effect against peanut sensitization.
Expecting Mother's Study of Consumption or Avoidance of ...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 ...
Study to Test if Mothers' Diet Prevents Early Sign of Food ...The new clinical trial aims to clearly determine the efficacy of including peanuts and eggs in expecting mothers' diets before and after birth ...
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