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


METHODS
Prospective randomized controlled study.


METHODS
Italy.


METHODS
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.
Savino
F
F
Department of Paediatrics, University of Turin, Turin, Italy. francesco.savino@unito.it
Palumeri
E
E
Castagno
E
E
Cresi
F
F
Dalmasso
P
P
Cavallo
F
F
Oggero
R
R
D003085:Colic / Q000178:diet therapy* / Q000453:epidemiology; D003448:Crying; D004044:Dietary Proteins / Q000627:therapeutic use*; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007231:Infant, Newborn; D008297:Male; D008894:Milk Proteins / Q000627:therapeutic use; D009844:Oligosaccharides / Q000627:therapeutic use; D019308:Palmitic Acid / Q000627:therapeutic use*; D011446:Prospective Studies; D011492:Protein Hydrolysates / Q000627:therapeutic use*; D012841:Simethicone / Q000627:therapeutic use; D016896:Treatment Outcome; D000067816:Whey Proteins
D004044:Dietary Proteins; D004643:Emollients; D008894:Milk Proteins; D009844:Oligosaccharides; D011492:Protein Hydrolysates; D000067816:Whey Proteins; D019308:Palmitic Acid; D012841:Simethicone