To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).
A prospective, randomised, double-blind, placebo-controlled crossover trial.
Two study sites in Italy and The Netherlands.
Children with documented cow's milk allergy were eligible for inclusion in this trial.
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 108 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.
For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.
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.
Hypoallergenic extensively hydrolysed (EH) cow's milk-based or amino acid-based formulae are recommended for management of cow's milk allergy in formula-fed infants.
Although Lactobacillus rhamnosus GG (LGG) has over 25 years of safe use as a dietary probiotic, the safety and hypoallergenic status of EH casein formula supplemented with LGG has not yet been demonstrated.
Supplementing the EH casein formula with LGG to provide additional benefits does not change its hypoallergenic status.
The LGG-supplemented EH formula can be safely used for management of cow's milk allergy in infants and children.
Strengths and limitations of this study
Testing the LGG-supplemented EH formula in a properly designed double-blind placebo-controlled food challenge in accordance with accepted European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) and American Academy of Pediatrics standards to establish hypoallergenicity is a major strength of this study.
One limitation is the potentially low novelty of our finding. Because LGG is the most used dietary probiotic, accumulated safety data for LGG as a stand-alone dietary supplement in infants and adults are available.