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Updated: Jun 14, 2026

Basophil Activation Test for Allergy Diagnosis
Published on: May 31, 2021
Open challenge for the diagnosis of cow's milk protein allergy
Fernanda Ferreira Correa1, Mário César Vieira, Danielle Reis Yamamoto
1Disciplina de Gastroenterologia Pediátrica, Universidade Federal de São Paulo, São Paulo, SP, Brazil.
Insights
Cow's milk open challenge tests helped stop exclusion diets for many children with cow's milk allergy. This study evaluated the safety and efficacy of these tests in young patients.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Nutrition
- Immunology
Background:
- Cow's milk allergy (CMA) is common in infants and children.
- Exclusion diets are standard management, but prolonged unnecessary restriction can impact nutrition.
- Reintroduction of cow's milk protein is crucial for tolerance development.
Purpose of the Study:
- To evaluate the results of supervised open cow's milk challenge tests in children on a cow's milk-free diet.
- To determine the rate of positive challenges and clinical outcomes.
- To assess the feasibility of discontinuing exclusion diets based on challenge results.
Main Methods:
- A cross-sectional study involving 121 children (4-95 months) on cow's milk-free diets.
- Supervised open cow's milk challenge tests conducted in a hospital setting with 30-day ambulatory follow-up.
- Analysis of challenge results, clinical manifestations, and types of prior exclusion diets.
Main Results:
- Cow's milk open challenge tests were positive in 28.1% of patients (23.1%).
- Among those with positive challenges, 24.9% showed different clinical manifestations than at diagnosis.
- Positive challenges were more frequent in infants fed extensively hydrolyzed or amino acid-based formulae (30.3%) compared to other exclusion diets (14.5%).
Conclusions:
- Open challenge tests are effective in identifying children who can safely reintroduce cow's milk.
- The procedure allows for the discontinuation of exclusion diets in a significant proportion of patients.
- Supervised challenges are a valuable tool in managing cow's milk allergy.
Objective:
To report the results of open challenge tests performed in children fed with cow's milk-free diet.
Description:
Cross-sectional study evaluating cow's milk open challenge performed under supervision in a hospital setting during 2.5 hours and ambulatory follow-up for 30 days when no immediate reaction occurred. One hundred and twenty-one patients were included, with ages between 4 and 95 months. Cow's milk open challenge tests were positive in 28 patients (23.1%). A clinical manifestation of cow's milk allergy different from the one presented at diagnosis occurred in 12 (24.9%) patients with positive challenge. Positive challenge was more frequent (p = 0.042) in patients fed with extensively hydrolyzed formulae or amino acid-based formulae (30.3%) when compared to those fed with other exclusion diets (14.5%).
Conclusion:
Open challenge allowed the interruption of exclusion diet in a significant proportion of the patients.
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