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A randomized, single-blind and crossover study of an amino acid-based milk formula in treating young children with
Ting Fan Leung1, Kwok Chiu Ma, Lorena T F Cheung
1Department of Paediatrics, The Chinese University of Hong Kong, Hong Kong. leung2142@cuhk.edu.hk
Insights
Amino acid-based formula did not significantly improve atopic dermatitis (AD) in young children, regardless of food allergy status. This study found no substantial benefits for AD control using this specialized formula in the tested age group.
Area of Science:
- Pediatric Allergy and Immunology
- Dermatology
- Clinical Nutrition
Background:
- Atopic dermatitis (AD) in young children is often linked to cow's milk and soy protein allergies.
- Amino acid (AA)-based elemental formulas are considered for managing AD in sensitive children.
- The efficacy of AA-based formula in AD patients, irrespective of specific food allergies, requires further investigation.
Purpose of the Study:
- To evaluate the effectiveness of amino acid (AA)-based elemental milk formula in improving atopic dermatitis (AD) control in young children.
- To assess the impact of AA-based formula on AD severity regardless of the patient's confirmed food allergy status.
- To compare the outcomes of AA-based formula against standard formulas in a pediatric AD cohort.
Main Methods:
- A randomized, crossover study design was employed with young children diagnosed with AD.
- Participants underwent allergy testing (skin prick tests, IgE assays) to determine sensitization.
- Patients received either AA-based formula or a placebo formula for 6 weeks, followed by a crossover period.
Main Results:
- No statistically significant improvements were observed in SCORAD scores or other clinical measures with AA-based formula.
- Urinary eosinophil protein X (EPX) concentration showed no significant change, except for a borderline carry-over effect (p=0.05).
- Eleven out of fifteen recruited patients completed the study, with a median age of 1.4 years and median SCORAD of 23.9.
Conclusions:
- The study does not support the routine use of amino acid (AA)-based elemental milk formula for treating atopic dermatitis in young children.
- Current evidence does not indicate significant clinical benefit of AA-based formula for pediatric AD, irrespective of food allergy.
- Further research may be needed to identify specific subgroups of pediatric AD patients who might benefit from elemental formulas.
Abstract:
Cow's milk and soy protein allergies are commonly associated with atopic dermatitis (AD) in young children. Amino acid (AA)-based elemental milk formula may improve AD control in these patients. This study investigates the efficacy of AA-based formula in treating young AD patients irrespective of their food allergy status. AD patients younger than 3 yr old were eligible. Sensitization to food allergens was ascertained by skin prick tests and allergen-specific immunoglobulin E (IgE) assay. Patients were then randomly allocated to take either active treatment or pre-existing formulae (placebo) for 6 wk. They were allowed a 6-wk washout period before crossed over to the other intervention for another 6 wk. Fifteen AD patients, with median (interquartile range, IQR) age of 1.4 (0.6-2.6) yr, were recruited. Their median (IQR) SCORAD score was 23.9 (10.5-29.7). Seven of them were sensitized to cow's milk or soybean. Among 11 patients who completed the study, the median changes for all scores and urinary eosinophil protein X (EPX) concentration were not statistically significant. There was also no evidence of carry-over effects for SCORAD and its various components and global health score, except for urinary EPX concentration (p = 0.05). Our results do not support the use of AA-based elemental milk formula in treating young children with AD irrespective of their food allergy status.
