Randomized placebo-controlled trial of hen's egg consumption for primary prevention in infants
Bellach J, Schwarz V, Ahrens B, Trendelenburg V, Aksünger Ö, Kalb B, Niggemann B, Keil T, Beyer K
The Journal of allergy and clinical immunology · 157 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
- Consumo medido con
- Comida provista por los investigadores
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Charité – Universitätsmedizin Berlin
- Organización sin fines de lucro
- Food Allergy & Anaphylaxis Network
- Organización sin fines de lucro
- Prevention and Information Network for Allergy/Asthma
Según 3 financiadores declarados.
Publicación
- Publicado
- 2016-08-12 · J Allergy Clin Immunol · vol. 139 · número 5 · págs. 1591–1599.e2
- Editorial
- Elsevier BV
- Citado
- 235 citas · más que el 100% de estudios similares · 24.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Food Allergy and Anaphylaxis Research · Drug-Induced Adverse Reactions · Eosinophilic Esophagitis
- Palabras clave
- egg allergy, early allergen introduction, infant weaning, primary prevention, egg white powder, egg-free diet, specific IgE sensitization, double-blind placebo-controlled food challenge, anaphylaxis, food allergy prevention
- MeSH
- animals, chickens, humans, anaphylaxis, egg hypersensitivity, immunoglobulin e, egg proteins, double-blind method, primary prevention, egg white, infant, female, male
9 autores
- Johanna Bellach🇩🇪Charité - Universitätsmedizin Berlin
- Veronika Schwarz🇩🇪Charité - Universitätsmedizin Berlin
- Birgit Ahrens🇩🇪Charité - Universitätsmedizin Berlin
- Valérie Trendelenburg🇩🇪Charité - Universitätsmedizin Berlin
- Özlem Aksünger🇩🇪Charité - Universitätsmedizin Berlin
- Birgit Kalb🇩🇪Charité - Universitätsmedizin Berlin
- B. Niggemann🇩🇪Charité - Universitätsmedizin Berlin
- Thomas Oskar Philipp Keil🇩🇪Charité - Universitätsmedizin Berlin
- Kirsten Beyer🇩🇪🇺🇸 · autor de correspondenciaCharité - Universitätsmedizin Berlin; Icahn School of Medicine at Mount Sinai
Resumen
El texto original del estudio, en el idioma en que se publicó.
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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