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Eur J Clin Nutr. 2006 Nov;60(11):1304-10. Epub 2006 May 31.

Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant formula.

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  • 1Department of Paediatrics, University of Turin, Turin, Italy. francesco.savino@unito.it

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 beta-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.

PMID:
16736065
[PubMed - indexed for MEDLINE]
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