Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial

Pediatrics. 2000 Dec;106(6):1349-54. doi: 10.1542/peds.106.6.1349.


Objective: To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands.

Study design: Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).

Main outcome measure: Difference in duration of crying (minutes per day) between qualification week and intervention week.

Results: Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.

Conclusions: An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Colic / etiology
  • Colic / prevention & control*
  • Crying*
  • Double-Blind Method
  • Female
  • Food Hypersensitivity / complications
  • Food Hypersensitivity / prevention & control*
  • Humans
  • Infant
  • Infant Food* / analysis
  • Male
  • Milk Proteins / analysis
  • Milk Proteins / pharmacology*
  • Protein Hydrolysates / analysis
  • Protein Hydrolysates / pharmacology*
  • Whey Proteins


  • Milk Proteins
  • Protein Hydrolysates
  • Whey Proteins