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

Eur J Clin Nutr. 2006 Nov;60(11):1304-10. doi: 10.1038/sj.ejcn.1602457. Epub 2006 May 31.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Colic / diet therapy*
  • Colic / epidemiology
  • Crying
  • Dietary Proteins / therapeutic use*
  • Emollients / therapeutic use
  • Female
  • Humans
  • Infant
  • Infant Formula*
  • Infant, Newborn
  • Male
  • Milk Proteins / therapeutic use
  • Oligosaccharides / therapeutic use
  • Palmitic Acid / therapeutic use*
  • Prospective Studies
  • Protein Hydrolysates / therapeutic use*
  • Simethicone / therapeutic use
  • Treatment Outcome
  • Whey Proteins


  • Dietary Proteins
  • Emollients
  • Milk Proteins
  • Oligosaccharides
  • Protein Hydrolysates
  • Whey Proteins
  • Palmitic Acid
  • Simethicone