Objective: To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).
Design: A prospective, randomised, double-blind, placebo-controlled crossover trial.
Setting: Two study sites in Italy and The Netherlands.
Study participants: Children with documented cow's milk allergy were eligible for inclusion in this trial.
Interventions: After a 7-day period of strict avoidance of cow's milk protein and other suspected food allergens, participants were tested with an EH casein formula with demonstrated hypoallergenicity (control, EHF) and a formula of the same composition with LGG added at 10(8) colony-forming units per gram powder (EHF-LGG) in randomised order in a double-blind placebo-controlled food challenge (DBPCFC). After absence of adverse reactions in the DBPCFC, an open challenge was performed with EHF-LGG, followed by a 7-day home feeding period with the same formula.
Main outcome measure: Clinical assessment of any adverse reactions to ingestion of study formulae during the DBPCFC.
Results: For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.
Conclusion: The EH casein formula supplemented with LGG is hypoallergenic and can be recommended for infants and children allergic to cow's milk who require an alternative to formulae containing intact cow's milk protein.
Trial registration number: http://ClinicalTrials.gov Identifier: NCT01181297.