Document Detail

Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant formula.
MedLine Citation:
PMID:  16736065     Owner:  NLM     Status:  MEDLINE    
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.
F Savino; E Palumeri; E Castagno; F Cresi; P Dalmasso; F Cavallo; R Oggero
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-05-31
Journal Detail:
Title:  European journal of clinical nutrition     Volume:  60     ISSN:  0954-3007     ISO Abbreviation:  Eur J Clin Nutr     Publication Date:  2006 Nov 
Date Detail:
Created Date:  2006-10-31     Completed Date:  2007-01-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8804070     Medline TA:  Eur J Clin Nutr     Country:  England    
Other Details:
Languages:  eng     Pagination:  1304-10     Citation Subset:  IM    
Department of Paediatrics, University of Turin, Turin, Italy.
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MeSH Terms
Colic / diet therapy*,  epidemiology
Dietary Proteins / therapeutic use*
Emollients / therapeutic use
Infant Formula*
Infant, Newborn
Milk Proteins / therapeutic use
Oligosaccharides / therapeutic use
Palmitic Acid / therapeutic use*
Prospective Studies
Protein Hydrolysates / therapeutic use*
Simethicone / therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Dietary Proteins; 0/Emollients; 0/Milk Proteins; 0/Oligosaccharides; 0/Protein Hydrolysates; 0/whey protein; 57-10-3/Palmitic Acid; 8050-81-5/Simethicone

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