Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial
- Antonella Muraro1,
- Maarten O Hoekstra2,
- Yolanda Meijer3,
- Carlos Lifschitz4,
- Jennifer L Wampler5,
- Cheryl Harris5,
- Deolinda M F Scalabrin5
- 1The Food Allergy Referral Centre, Department of Pediatrics, Veneto Region, Università degli Studi di Padova, Padova, Italy.
- 2Department of Paediatrics, University Medical Centre St Radboud, Nijmegen, The Netherlands
- 3Wilhelmina Childrens' Hospital, University Medical Centre, Utrecht, The Netherlands
- 4Departamento de Pediatria, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
- 5Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, Indiana, USA
- Correspondence to Dr Jennifer L Wampler;
- Received 16 November 2011
- Accepted 2 February 2012
- Published 5 March 2012
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 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.
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.
- Cow's milk protein
- cow's milk allergy
- extensively hydrolysed formula
- double-blind placebo-controlled food challenge
- hypoallergenic formula
- Lactobacillus GG
To cite: Muraro A, Hoekstra MO, Meijer Y, et al. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open 2012;2:e000637. doi:10.1136/bmjopen-2011-000637
Contributors AM, YM and MOH helped design the study, assessed study participants and collected study data, interpreted data and reviewed and revised the manuscript. CL interpreted data and reviewed and revised the manuscript. JLW and DMFS interpreted data and drafted the manuscript. CLH prepared and interpreted data and reviewed the manuscript. All authors contributed to the intellectual content and approved the final version.
Funding The study was funded by the study sponsor, Mead Johnson Nutrition (study number 3369-2). Mead Johnson Nutrition provided logistical support during the trial. Employees of the sponsor worked with study investigators to prepare the protocol, summarise the collected data and write the manuscript.
Competing interests AM, MOH and YM have received research support from Mead Johnson Nutrition. CHL is a former employee of Mead Johnson Nutrition. JLW, CLH and DMFS work in the Department of Medical Affairs at Mead Johnson Nutrition.
Patient consent All participant information was completely anonymised.
Ethics approval Ethical approval was obtained from Italy: Tesoriere Azienda Ospedaliera Padova and The Netherlands: Medisch Ethische Toetsingscommissie.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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