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Randomized placebo-controlled trial of hen's egg consumption for primary prevention in infants
Johanna Bellach1, Veronika Schwarz1, Birgit Ahrens1
1Department of Paediatric Pneumology and Immunology, Charité-Universitätsmedizin, Berlin, Germany.
Insights
Early introduction of hen's egg did not prevent allergy in infants. Introducing egg before 12 months may increase allergic reactions in infants already sensitized to egg.
Area of Science:
- Pediatric Allergy
- Immunology
- Clinical Nutrition
Background:
- Hen's egg allergy is a prevalent food allergy in early childhood.
- Early intervention strategies are crucial for managing childhood allergies.
Purpose of the Study:
- To evaluate the efficacy of early hen's egg introduction (4-6 months) in preventing hen's egg allergy.
- To assess the safety of early egg introduction in a general infant population.
Main Methods:
- A randomized, placebo-controlled trial involving 4- to 6-month-old infants without hen's egg sensitization.
- Infants received either egg white powder (verum) or rice powder (placebo) 3 times weekly until 12 months.
- Primary outcome: hen's egg sensitization (serum IgE levels); Secondary outcome: confirmed hen's egg allergy via food challenge.
Main Results:
- No significant difference in hen's egg sensitization or allergy between the verum and placebo groups at 12 months.
- The verum group showed a higher, though not statistically significant, risk for sensitization and allergy.
- A notable percentage of infants screened were already sensitized or allergic to hen's egg.
Conclusions:
- Early introduction of hen's egg (4-6 months) does not prevent sensitization or allergy in infants.
- Early introduction may increase the risk of allergic reactions in already sensitized infants.
- Current findings suggest caution regarding early egg introduction in the general infant population.
Background:
Hen's egg is the most common cause of food allergy in early childhood.
Objective:
We investigated the efficacy and safety of early hen's egg introduction at age 4 to 6 months to prevent hen's egg allergy in the general population.
Methods:
This randomized, placebo-controlled trial included 4- to 6-month-old infants who were not sensitized against hen's egg, as determined based on specific serum antibodies (IgE). These infants were randomized to receive either verum (egg white powder) or placebo (rice powder) added to the first weaning food 3 times a week under a concurrent egg-free diet from age 4 to 6 until 12 months. The primary outcome was sensitization to hen's egg (increased specific serum IgE levels) by age 12 months. Hen's egg allergy (secondary outcome) was confirmed by double-blind, placebo-controlled food challenges.
Results:
Among 406 screened infants, 23 (5.7%) had hen's egg-specific IgE before randomization. Seventeen of 23 underwent subsequent double-blind, placebo-controlled food challenges, and 16 were confirmed as allergic, including 11 with anaphylactic reactions. Of the 383 nonsensitized infants (56.7% male), 184 were randomized to verum and 199 to placebo. At 12 months of age, 5.6% of the children in the verum group were hen's egg sensitized versus 2.6% in the placebo group (primary outcome; relative risk, 2.20; 95% CI, 0.68-7.14; P = .24), and 2.1% were confirmed to have hen's egg allergy versus 0.6% in the placebo group (relative risk, 3.30; 95% CI, 0.35-31.32; P = .35).
Conclusion:
We found no evidence that consumption of hen's egg starting at 4 to 6 months of age prevents hen's egg sensitization or allergy. In contrast, it might result in frequent allergic reactions in the community considering that many 4- to 6-month-old infants were already allergic to hen's egg.
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