Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial

To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands. Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, form...

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Veröffentlicht in:Pediatrics (Evanston) 2000-12, Vol.106 (6), p.1349-1354
Hauptverfasser: Lucassen, Peter L. B. J, Assendelft, Willem J. J, Gubbels, Jan W, van Eijk, Jacques ThM, Douwes, Adriaan C
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container_end_page 1354
container_issue 6
container_start_page 1349
container_title Pediatrics (Evanston)
container_volume 106
creator Lucassen, Peter L. B. J
Assendelft, Willem J. J
Gubbels, Jan W
van Eijk, Jacques ThM
Douwes, Adriaan C
description To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands. 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, 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). Difference in duration of crying (minutes per day) between qualification week and intervention week. 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. An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.
doi_str_mv 10.1542/peds.106.6.1349
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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. 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Abdomen</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant Food - analysis</subject><subject>Infants</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Milk Proteins - analysis</subject><subject>Milk Proteins - pharmacology</subject><subject>Other diseases. Semiology</subject><subject>Pediatrics</subject><subject>Primary care</subject><subject>Protein Hydrolysates - analysis</subject><subject>Protein Hydrolysates - pharmacology</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. 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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Babies
Behavior
Biological and medical sciences
Clinical trials
Colic
Colic - etiology
Colic - prevention & control
Colic in infants
Crying
Diet therapy
Double-Blind Method
Drug therapy
Female
Food and nutrition
Food Hypersensitivity - complications
Food Hypersensitivity - prevention & control
Gastroenterology. Liver. Pancreas. Abdomen
Health aspects
Humans
Infant
Infant Food - analysis
Infants
Male
Medical sciences
Milk Proteins - analysis
Milk Proteins - pharmacology
Other diseases. Semiology
Pediatrics
Primary care
Protein Hydrolysates - analysis
Protein Hydrolysates - pharmacology
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Whey
Whey Proteins
title Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial
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