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Updated: Jul 8, 2026

Basophil Activation Test for Allergy Diagnosis
Published on: May 31, 2021
Dietary prevention of allergic diseases in infants and small children
Arne Høst1, Susanne Halken, Antonella Muraro
1Department of Pediatrics, Odense University Hospital, Odense, Denmark.
Insights
Excluding four trials from a meta-analysis on hydrolyzed protein formulas does not change recommendations for infant allergy prevention. Breastfeeding remains highly recommended for all infants, with specific diets for high-risk infants.
Area of Science:
- Pediatrics
- Allergology
- Clinical Immunology
Background:
- Four trials were excluded from a Cochrane meta-analysis on hydrolyzed protein formulas for infant allergy prevention due to scientific fraud.
- The Section on Paediatrics, European Academy of Allergology and Clinical Immunology (SP-EAACI) does not agree with the revised Cochrane review's conclusions regarding these exclusions.
Purpose of the Study:
- To evaluate the impact of excluding fraudulent trials on recommendations for primary dietary prevention of allergic diseases in infants.
- To assess the evidence base for infant feeding recommendations, considering methodological concerns in existing meta-analyses.
Main Methods:
- Analysis of published peer-reviewed observational and interventional studies.
- Inclusion of high-quality systematic reviews of high-quality cohort studies for evidence assessment, especially for breastfeeding where randomization is unethical.
- Evaluation of methodological quality of studies to determine the level of evidence.
Main Results:
- Despite trial exclusions, breastfeeding is strongly recommended for all infants, regardless of family history of allergies.
- Dietary interventions are effective in preventing allergic diseases in high-risk infants, particularly food allergy and eczema in early infancy.
- Exclusive breastfeeding for 4-6 months, or hypoallergenic formulas if breast milk is unavailable, combined with delayed introduction of solids and avoidance of cow's milk for the first 4 months, is the most effective dietary regimen.
Conclusions:
- The exclusion of four trials does not alter previous recommendations for primary dietary prevention of allergic diseases.
- Breastfeeding is a cornerstone of infant allergy prevention.
- Specific dietary strategies are recommended for high-risk infants to mitigate allergy development.
Abstract:
Because of scientific fraud four trials have been excluded from the original Cochrane meta-analysis on formulas containing hydrolyzed protein for prevention of allergy and food intolerance in infants. Unlike the conclusions of the revised Cochrane review the export group set up by the Section on Paediatrics, European Academy of Allergology and Clinical Immunology (SP-EAACI) do not find that the exclusion of the four trials demands a change of the previous recommendations regarding primary dietary prevention of allergic diseases. Ideally, recommendations on primary dietary prevention should be based only on the results of randomized and quasi-randomized trials (selection criteria in the Cochrane review). However, regarding breastfeeding randomization is unethical, Therefore, in the development of recommendations on dietary primary prevention, high-quality systematic reviews of high-quality cohort studies should be included in the evidence base. The study type combined with assessment of the methodological quality determines the level of evidence. In view of some methodological concerns in the Cochrane meta-analysis, particularly regarding definitions and diagnostic criteria for outcome measures and inclusion of non peer-reviewed studies/reports, a revision of the Cochrane analysis may seem warranted. Based on analysis of published peer-reviewed observational and interventional studies the results still indicate that breastfeeding is highly recommended for all infants irrespective of atopic heredity. A dietary regimen is effective in the prevention of allergic diseases in high-risk infants, particularly in early infancy regarding food allergy and eczema. The most effective dietary regimen is exclusively breastfeeding for at least 4-6 months or, in absence of breast milk, formulas with documented reduced allergenicity for at least the first 4 months, combined with avoidance of solid food and cow's milk for the first 4 months.
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