Abstract
Objectives:
The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins, prebiotic oligosaccharides (OS), with a high β-palmitic acid content.
Design:
Prospective randomized controlled study.
Setting:
Italy.
Subjects:
Two hundred and sixty-seven formula-fed infants, aged less than 4 months, with infantile colic, were randomized to receive either the new infant formula (study treatment (ST)) or a standard formula and simethicone (6 mg/kg twice a day) (control treatment (CT)). A questionnaire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time.
Results:
Out of the 199 infants who completed the study, 96 were treated with the new formula and 103 were not treated. Infants receiving the new formula had a significant decrease in colic episodes after 1 week (2.47±1.94 at day 7 vs 5.99±1.84 at the study entry) compared to infants receiving the CT (3.72±1.98 at day 7 vs 5.41±1.88 at the study entry) (P<0.0001). Also at day 14, the crying episodes were significantly different between the two groups of infants (1.76±1.60 in ST vs 3.32±2.06 in CT) (P<0.0001).
Conclusions:
The use of a partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a standard formula and simethicone.
Sponsorship:
The study was supported by funds from Numico, Italy.
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Acknowledgements
We acknowledge the work was partially funded by a grant from Numico, Italy.
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Guarantor: F Savino.
Contributors: FS directed and supervised the overall programme, and was responsible for study design. EP and EC were the principal investigators and were responsible for implementing the programme, data collection and editing of the paper. FC was responsible for data analysis and drafting of the paper. PD and FC contributed to the programme design and statistical analysis. RO was responsible for medical aspects of the programme, and contributed to the writing and editing of the paper.
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Savino, F., Palumeri, E., Castagno, E. et al. Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula. Eur J Clin Nutr 60, 1304–1310 (2006). https://doi.org/10.1038/sj.ejcn.1602457
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DOI: https://doi.org/10.1038/sj.ejcn.1602457
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