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Journal ArticleDOI

Early regular egg exposure in infants with eczema : a randomized controlled trial

TL;DR: In this article, the authors sought to determine whether early regular ingestion of allergenic foods might reduce the risk of food allergy, and they found that early-regular ingestion of foods may reduce the food allergy risk.
Abstract: Background: Observational studies suggest that early regular ingestion of allergenic foods might reduce the risk of food allergy. Objective: We sought to determine whether early regular oral egg ex ...

Summary (2 min read)

Introduction

  • With rising rates of food allergy 2 , there is ongoing confusion and controversy over the role of allergenic foods in the development of food allergy.
  • Until recently, it has been common practice to avoid egg and other allergenic foods for the primary prevention of food allergy 3 .
  • It is recognized that the level of evidence in this area is generally weak, based largely on observational studies with methodological limitations and that randomized control trials are needed to address this more conclusively.
  • Animal studies have shown that the development of oral tolerance is driven by regular allergen exposure and that avoidance strategies may increase the risk of adverse immune responses to allergens 8 .
  • Here the authors report the first randomized controlled trial to investigate whether early introduction of egg reduces the risk of egg allergy in infants with a history of eczema.

Study design

  • Singleton, term infants with symptoms of moderate to severe eczema (determined using a standardized scoring system for atopic dermatitis/eczema.
  • The study was conducted using a double-blinded randomized controlled trial design.
  • Baseline characteristics including maternal age at birth, maternal race, Caesarean delivery, smoking in the household, family (first degree relative) history of allergic disease, infant sex, infant dietary information on breastfeeding and/or formula feeding, infant history of and treatments used for eczema were recorded at randomization at 4-months of age.
  • A blood sample was collected prior to the first exposure to the study powder.
  • Baseline egg-specific IgE and IgG4 levels were analyzed at the completion of the trial, and did not influence eligibility.

Infant Allergic Disease Outcome Assessments

  • At each contact time point with the families, questions were asked relating to compliance with the dietary intervention, infant feeding, egg intake, symptoms of allergic disease, doctor visits for eczema and the use of any treatment medications for eczema.
  • At the 8 and 12 month appointments, the infant's eczema was assessed using SCORAD 20 and a blood sample was collected to measure whole egg-specific IgE and egg white-specific IgG4 serum antibody concentrations (see the on-line repository for more details).
  • Throughout this trial an allergic reaction was defined as at least 3 concurrent non-contact urticaria persisting for at least 5 minutes and/or generalised skin erythema (but not an exacerbation of eczema alone) and/or vomiting (forceful/projectile) and/or anaphylaxis (evidence of circulatory or respiratory involvement).
  • Serious adverse events were reviewed by a Serious Adverse Event Committee and any such events were reported to the Human Research Ethics Committees.
  • At 8-months of age, all participating infants had a medically supervised cooked egg exposure, where the infant was given 2 teaspoons of mashed hard-boiled whole egg (equivalent to 1/6 of an egg) to eat and observed for at least 2 hours afterwards.

Results

  • 86 infants were randomized into the trial, 49 infants to the egg group and 37 infants to the rice group.
  • There were no significant differences in the baseline characteristics between the two groups (Table 1 ).

Intervention, compliance and safety

  • A high proportion (21%) of infants randomized (18/86) had an allergic reaction to their allocated study powder.
  • For the infants without an allergic reaction to the study powder, compliance with the powder use was high.
  • Compliance with the inclusion of cooked egg into the diet of the infants, who did not react to the cooked egg exposure, from 8-12 months of age was high with all of these infants (n=63) consuming egg as an ingredient in foods, and 59/63 (94%) infants consuming whole egg as either quiche, omelette, hard-boiled or scrambled egg.
  • In the rice group, two infants had anaphylaxis, one after the cooked egg exposure and one after the pasteurized raw egg challenge.

IgE and IgG4 antibody measurements

  • There were no differences in baseline egg-specific IgE levels between the groups or at any other time point (Table 3 ).
  • Early ingestion of egg (egg group) was associated with significantly (P<0.001) and persistently higher egg-specific IgG4 levels .

Discussion

  • This is the first reported RCT to investigate the hypothesis that early regular oral exposure to an allergenic food can induce oral tolerance and reduce the risk of subsequent food allergy.
  • This study was terminated early for logistic reasons (see methods) and the authors acknowledge that this is a major limitation due to the resulting insufficient power to show statistically Palmer 17 significant definitive results.
  • The authors chose a particularly allergenic form of egg for the intervention group study powder, namely pasteurized raw egg, which has equivalent allergenic properties to that of raw egg 24 .

Conclusion

  • Induction of immune tolerance pathways and reduction in the egg allergy rate may be achieved by early regular oral exposure to egg from 4-months of age in infants with moderate Palmer 18 to severe eczema.
  • Caution needs to be taken when these high-risk infants are first exposed to egg as many have already developed sensitization and clinical reactivity by 4-months of age.
  • This points to much earlier events in the initiation of food sensitization, well before the introduction of complementary feeding.

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SUBMITTED VERSION
Debra J. Palmer, Jessica Metcalfe, Maria Makrides, Michael S. Gold, Patrick Quinn,
Christina E. West, Richard Loh, and Susan L. Prescott
Early regular egg exposure in infants with eczema: a randomized controlled trial
Journal of Allergy and Clinical Immunology, 2013; 132(2):387-392
Copyright © 2013 American Academy of Allergy, Asthma & Immunology
http://hdl.handle.net/2440/79922
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26 August 2015

Palmer 1
Early regular egg exposure in infants with eczema: a randomized controlled trial. 1
2
Debra J. Palmer, PhD
a,b
, Jessica Metcalfe, BSc
a
, Maria Makrides, PhD
b,c
, Michael S. Gold, 3
MD
c,d
, Patrick Quinn, MD
d
, Christina E. West, MD, PhD
a,e
, Richard Loh, MD
f
and Susan L. 4
Prescott, MD, PhD
a,f
5
6
a
School of Paediatrics and Child Health, The University of Western Australia (M561), 35 7
Stirling Highway, Crawley, Western Australia, 6009, Australia. 8
b
Women’s & Children’s Health Research Institute, 72 King William Road, North Adelaide, 9
South Australia, 5006, Australia. 10
c
School of Paediatrics and Reproductive Health, University of Adelaide, Children, Youth and 11
Women’s Health Service, 72 King William Road, North Adelaide, South Australia, 5006, 12
Australia. 13
d
Children, Youth and Women’s Health Service, 72 King William Road, North Adelaide, 14
South Australia, 5006, Australia. 15
e
Department of Clinical Sciences, Pediatrics, Umeå University, 901 85 Umeå, Sweden. 16
f
Department of Immunology, Princess Margaret Hospital, Roberts Rd, Subiaco, Western 17
Australia 6008, Australia. 18
19
Correspondence to: A/Prof Debra Palmer 20
Address: School of Paediatrics and Child Health, The University of Western Australia 21
(M561), 35 Stirling Highway, Crawley, Western Australia, 6009, Australia 22
Telephone number: +61 (0)8 9340 8834 23
Fax number: +61 (0)8 9388 2097 24
Email: debbie.palmer@uwa.edu.au 25

Palmer 2
26
Funding Declaration: The trial was supported by a grant from the Women’s and Children’s 27
Hospital Foundation and a grant from the Ilhan Food Allergy Foundation. 28
29
30

Palmer 3
Abstract 31
Background: Observational studies suggest that early regular ingestion of allergenic foods 32
may reduce the risk of food allergy. 33
Objective: To determine if early regular oral egg exposure will reduce subsequent IgE-34
mediated egg allergy in infants with moderate to severe eczema. 35
Methods: In a double-blinded randomized controlled trial, infants were allocated to one 36
teaspoon of pasteurized raw whole egg powder (n=49) or rice powder (n=37) daily from 4-8-37
months of age. Cooked egg was introduced to both groups after an observed feed at 8-38
months. The primary outcome was IgE-mediated egg allergy at 12-months defined by an 39
observed pasteurized raw egg challenge and skin prick tests. 40
Results: A high proportion (31%) of infants randomized to receive egg (15/49) had an 41
allergic reaction to the egg powder and did not continue powder ingestion. At 4-months of 42
age, prior to any known egg ingestion, 36% (24/67) infants already had egg-specific IgE 43
>0.35 kU
A
/L. At 12-months, a lower (but not significant) proportion of infants in the egg 44
group (33%) were diagnosed with IgE-mediated egg allergy compared to the control group 45
(51%; relative risk 0.65; 95% confidence intervals 0.38 to 1.11; P=0.11). Egg-specific IgG4 46
levels were significantly (P<0.001) higher in the egg group at both 8 and 12-months. 47
Conclusion: Induction of immune tolerance pathways and reduction in egg allergy incidence 48
may be achieved by early regular oral egg exposure in infants with eczema. Caution needs to 49
be taken when these high-risk infants are first exposed to egg as many have already 50
developed sensitization by 4-months of age. 51
52
53

Palmer 4
Clinical Implications 54
Caution needs to be taken when infants with moderate to severe eczema are first exposed to 55
egg as many have already developed sensitization and clinical reactivity by 4-months of age. 56
57
Capsule Summary 58
Induction of immune tolerance pathways and reduction in egg allergy incidence may be 59
achieved by early regular oral egg exposure in infants with eczema provided the infant 60
tolerates their first few exposures to egg. 61
62
Key words 63
Allergy prevention, complementary feeding, eczema, egg, food allergy, oral tolerance, 64
randomized controlled trial. 65
66
Abbreviations 67
CI - confidence intervals 68
IgE - immunoglobulin E 69
IgG4 - immunoglobulin G4 70
ITT - intention to treat 71
RCT - randomized controlled trial 72
RR - relative risk 73
SCORAD - scoring system for atopic dermatitis/eczema 74
SOTI - specific oral tolerance induction 75
SPT - skin prick test 76
77

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TL;DR: The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts.
Abstract: Methods We randomly assigned 640 infants with severe eczema, egg allergy, or both to consume or avoid peanuts until 60 months of age. Participants, who were at least 4 months but younger than 11 months of age at randomization, were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract, which was determined with the use of a skin-prick test — one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter. The primary outcome, which was assessed independently in each cohort, was the proportion of participants with peanut allergy at 60 months of age. Results Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test, the prevalence of peanut allergy at 60 months of age was 13.7% in the avoidance group and 1.9% in the consumption group (P<0.001). Among the 98 participants in the intention-to-treat population who initially had positive test results, the prevalence of peanut allergy was 35.3% in the avoidance group and 10.6% in the consumption group (P = 0.004). There was no significant between-group difference in the incidence of serious adverse events. Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody. A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4:IgE were associated with peanut allergy. Conclusions The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00329784.)

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Abstract: This review provides general information to serve as a primer for those embarking on understanding food allergy and also details advances and updates in epidemiology, pathogenesis, diagnosis, and treatment that have occurred over the 4 years since our last comprehensive review. Although firm prevalence data are lacking, there is a strong impression that food allergy has increased, and rates as high as approximately 10% have been documented. Genetic, epigenetic, and environmental risk factors are being elucidated increasingly, creating potential for improved prevention and treatment strategies targeted to those at risk. Insights on pathophysiology reveal a complex interplay of the epithelial barrier, mucosal and systemic immune response, route of exposure, and microbiome among other influences resulting in allergy or tolerance. The diagnosis of food allergy is largely reliant on medical history, tests for sensitization, and oral food challenges, but emerging use of component-resolved diagnostics is improving diagnostic accuracy. Additional novel diagnostics, such as basophil activation tests, determination of epitope binding, DNA methylation signatures, and bioinformatics approaches, will further change the landscape. A number of prevention strategies are under investigation, but early introduction of peanut has been advised as a public health measure based on existing data. Management remains largely based on allergen avoidance, but a panoply of promising treatment strategies are in phase 2 and 3 studies, providing immense hope that better treatment will be imminently and widely available, whereas numerous additional promising treatments are in the preclinical and clinical pipeline.

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TL;DR: The trial did not show the efficacy of early introduction of allergenic foods in an intention-to-treat analysis, and the consumption of 2 g per week of peanut or egg-white protein was associated with a significantly lower prevalence of these respective allergies than was less consumption.
Abstract: BackgroundThe age at which allergenic foods should be introduced into the diet of breast-fed infants is uncertain. We evaluated whether the early introduction of allergenic foods in the diet of breast-fed infants would protect against the development of food allergy. MethodsWe recruited, from the general population, 1303 exclusively breast-fed infants who were 3 months of age and randomly assigned them to the early introduction of six allergenic foods (peanut, cooked egg, cow’s milk, sesame, whitefish, and wheat; early-introduction group) or to the current practice recommended in the United Kingdom of exclusive breast-feeding to approximately 6 months of age (standard-introduction group). The primary outcome was food allergy to one or more of the six foods between 1 year and 3 years of age. ResultsIn the intention-to-treat analysis, food allergy to one or more of the six intervention foods developed in 7.1% of the participants in the standard-introduction group (42 of 595 participants) and in 5.6% of thos...

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TL;DR: All infants should receive iron-rich CF including meat products and/or iron-fortified foods and no sugar or salt should be added to CF and fruit juices or sugar-sweetened beverages should be avoided.
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TL;DR: Early egg or peanut introduction to the infant diet was associated with lower risk of developing Egg or peanut allergy and timing of allergenic food introduction was not associated with risk of allergy to other foods.
Abstract: Importance Timing of introduction of allergenic foods to the infant diet may influence the risk of allergic or autoimmune disease, but the evidence for this has not been comprehensively synthesized. Objective To systematically review and meta-analyze evidence that timing of allergenic food introduction during infancy influences risk of allergic or autoimmune disease. Data Sources MEDLINE, EMBASE, Web of Science, CENTRAL, and LILACS databases were searched between January 1946 and March 2016. Study Selection Intervention trials and observational studies that evaluated timing of allergenic food introduction during the first year of life and reported allergic or autoimmune disease or allergic sensitization were included. Data Extraction and Synthesis Data were extracted in duplicate and synthesized for meta-analysis using generic inverse variance or Mantel-Haenszel methods with a random-effects model. GRADE was used to assess the certainty of evidence. Main Outcomes and Measures Wheeze, eczema, allergic rhinitis, food allergy, allergic sensitization, type 1 diabetes mellitus, celiac disease, inflammatory bowel disease, autoimmune thyroid disease, and juvenile rheumatoid arthritis. Results Of 16 289 original titles screened, data were extracted from 204 titles reporting 146 studies. There was moderate-certainty evidence from 5 trials (1915 participants) that early egg introduction at 4 to 6 months was associated with reduced egg allergy (risk ratio [RR], 0.56; 95% CI, 0.36-0.87; I2 = 36%; P = .009). Absolute risk reduction for a population with 5.4% incidence of egg allergy was 24 cases (95% CI, 7-35 cases) per 1000 population. There was moderate-certainty evidence from 2 trials (1550 participants) that early peanut introduction at 4 to 11 months was associated with reduced peanut allergy (RR, 0.29; 95% CI, 0.11-0.74; I2 = 66%; P = .009). Absolute risk reduction for a population with 2.5% incidence of peanut allergy was 18 cases (95% CI, 6-22 cases) per 1000 population. Certainty of evidence was downgraded because of imprecision of effect estimates and indirectness of the populations and interventions studied. Timing of egg or peanut introduction was not associated with risk of allergy to other foods. There was low- to very low-certainty evidence that early fish introduction was associated with reduced allergic sensitization and rhinitis. There was high-certainty evidence that timing of gluten introduction was not associated with celiac disease risk, and timing of allergenic food introduction was not associated with other outcomes. Conclusions and Relevance In this systematic review, early egg or peanut introduction to the infant diet was associated with lower risk of developing egg or peanut allergy. These findings must be considered in the context of limitations in the primary studies.

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References
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TL;DR: There is insufficient data to document a protective effect of any dietary intervention beyond 4 to 6 months of age for the development of atopic disease, and current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation.
Abstract: This clinical report reviews the nutritional options during pregnancy, lactation, and the first year of life that may affect the development of atopic disease (atopic dermatitis, asthma, food allergy) in early life. It replaces an earlier policy statement from the American Academy of Pediatrics that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease. The documented benefits of nutritional intervention that may prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy (ie, infants with at least 1 first-degree relative [parent or sibling] with allergic disease). Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation. There is evidence that breastfeeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood. In studies of infants at high risk of atopy and who are not exclusively breastfed for 4 to 6 months, there is modest evidence that the onset of atopic disease may be delayed or prevented by the use of hydrolyzed formulas compared with formula made with intact cow milk protein, particularly for atopic dermatitis. Comparative studies of the various hydrolyzed formulas also indicate that not all formulas have the same protective benefit. There is also little evidence that delaying the timing of the introduction of complementary foods beyond 4 to 6 months of age prevents the occurrence of atopic disease. At present, there are insufficient data to document a protective effect of any dietary intervention beyond 4 to 6 months of age for the development of atopic disease.

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TL;DR: It is prudent to avoid both early and late introduction of gluten, and to introduce gluten gradually while the infant is still breast-fed, inasmuch as this may reduce the risk of celiac disease, type 1 diabetes mellitus, and wheat allergy.
Abstract: This position paper on complementary feeding summarizes evidence for health effects of complementary foods. It focuses on healthy infants in Europe. After reviewing current knowledge and practices, we have formulated these conclusions: Exclusive or full breast-feeding for about 6 months is a desirable goal. Complementary feeding (ie, solid foods and liquids other than breast milk or infant formula and follow-on formula) should not be introduced before 17 weeks and not later than 26 weeks. There is no convincing scientific evidence that avoidance or delayed introduction of potentially allergenic foods, such as fish and eggs, reduces allergies, either in infants considered at increased risk for the development of allergy or in those not considered to be at increased risk. During the complementary feeding period, >90% of the iron requirements of a breast-fed infant must be met by complementary foods, which should provide sufficient bioavailable iron. Cow's milk is a poor source of iron and should not be used as the main drink before 12 months, although small volumes may be added to complementary foods. It is prudent to avoid both early ( or=7 months) introduction of gluten, and to introduce gluten gradually while the infant is still breast-fed, inasmuch as this may reduce the risk of celiac disease, type 1 diabetes mellitus, and wheat allergy. Infants and young children receiving a vegetarian diet should receive a sufficient amount ( approximately 500 mL) of breast milk or formula and dairy products. Infants and young children should not be fed a vegan diet.

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TL;DR: The extent of lesions according to the rule of nines showed interobserver variability mostly for patients with lesions of moderate intensity involving 20-60% of body surface, but variations subsided especially for oozing/crusts and lichenifications.
Abstract: Background: We have previously reported how the SCORAD index was designed. This cumulative index combines objective (extent and intensity of lesions) and subjective (daytime pruritu

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TL;DR: In this paper, the authors measured the prevalence of common IgE-mediated childhood food allergies in a population-based sample of 12-month-old infants by using predetermined food challenge criteria to measure outcomes.
Abstract: Background: Several indicators suggest that food allergy in infants is common and possibly increasing. Few studies have used oral food challenge to measure this phenomenon at the population level. Objective: To measure the prevalence of common IgE-mediated childhood food allergies in a population-based sample of 12-month-old infants by using predetermined food challenge criteria to measure outcomes. Methods: A sampling frame was used to select recruitment areas to attain a representative population base. Recruitment occurred at childhood immunization sessions in Melbourne, Australia. Infants underwent skin prick testing, and those with any sensitization (wheal size ≥1 mm) to 1 or more foods (raw egg, peanut, sesame, shellfish, or cow's milk) were invited to attend an allergy research clinic. Those who registered a wheal size ≥1 mm to raw egg, peanut, or sesame underwent oral food challenge. Results: Amongst 2848 infants (73% participation rate), the prevalence of any sensitization to peanut was 8.9% (95% CI, 7.9-10.0); raw egg white, 16.5% (95% CI, 15.1-17.9); sesame, 2.5% (95% CI, 2.0-3.1); cow's milk, 5.6% (95% CI, 3.2-8.0); and shellfish, 0.9% (95% CI, 0.6-1.5). The prevalence of challenge-proven peanut allergy was 3.0% (95% CI, 2.4-3.8); raw egg allergy, 8.9% (95% CI, 7.8-10.0); and sesame allergy, 0.8% (95% CI, 0.5-1.1). Oral food challenges to cow's milk and shellfish were not performed. Of those with raw egg allergy, 80.3% could tolerate baked egg. Conclusion: More than 10% of 1-year-old infants had challenge-proven IgE-mediated food allergy to one of the common allergenic foods of infancy. The high prevalence of allergic disease in Australia requires further investigation and may be related to modifiable environmental factors.

866 citations

Journal ArticleDOI
TL;DR: These results show that oral immunotherapy can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness in a clinically significant subset.
Abstract: BACKGROUND For egg allergy, dietary avoidance is the only currently approved treatment. We evaluated oral immunotherapy using egg-white powder for the treatment of children with egg allergy. METHODS In this double-blind, randomized, placebo-controlled study, 55 children, 5 to 11 years of age, with egg allergy received oral immunotherapy (40 children) or placebo (15). Initial dose-escalation, build-up, and maintenance phases were followed by an oral food challenge with egg-white powder at 10 months and at 22 months. Children who successfully passed the challenge at 22 months discontinued oral immunotherapy and avoided all egg consumption for 4 to 6 weeks. At 24 months, these children underwent an oral food challenge with egg-white powder and a cooked egg to test for sustained unresponsiveness. Children who passed this challenge at 24 months were placed on a diet with ad libitum egg consumption and were evaluated for continuation of sustained unresponsiveness at 30 months and 36 months. RESULTS After 10 months of therapy, none of the children who received placebo and 55% of those who received oral immunotherapy passed the oral food challenge and were considered to be desensitized; after 22 months, 75% of children in the oral-immunotherapy group were desensitized. In the oral-immunotherapy group, 28% (11 of 40 children) passed the oral food challenge at 24 months and were considered to have sustained unresponsiveness. At 30 months and 36 months, all children who had passed the oral food challenge at 24 months were consuming egg. Of the immune markers measured, small wheal diameters on skin-prick testing and increases in eggspecific IgG4 antibody levels were associated with passing the oral food challenge at 24 months. CONCLUSIONS These results show that oral immunotherapy can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness in a clinically significant subset. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00461097.)

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In this paper, a double-blinded randomized controlled trial was conducted to determine if early regular oral egg exposure will reduce subsequent IgE-mediated egg allergy in infants with moderate to severe eczema.