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Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant
F Savino1, E Palumeri, E Castagno
1Department of Paediatrics, University of Turin, Turin, Italy. francesco.savino@unito.it
Insights
A new infant formula with partially hydrolyzed whey proteins and prebiotics significantly reduced crying episodes in colicky infants. This specialized formula offers a promising alternative for managing infant colic.
Area of Science:
- Pediatrics
- Infant Nutrition
- Gastroenterology
Background:
- Infantile colic is a common condition characterized by excessive crying in healthy infants.
- Current management strategies for infantile colic include behavioral interventions and pharmacological treatments.
- Dietary interventions, such as specialized infant formulas, are explored for their efficacy in managing colic symptoms.
Purpose of the Study:
- To evaluate the effectiveness of a novel infant formula in reducing crying episodes associated with infantile colic.
- The study assessed a formula containing partially hydrolyzed whey proteins, prebiotic oligosaccharides (OS), and high beta-palmitic acid content.
Main Methods:
- A prospective randomized controlled study was conducted in Italy.
- 267 infants under 4 months with colic were randomized to receive either the new formula (study treatment) or a standard formula with simethicone (control treatment).
- Parental questionnaires tracked daily colic episodes and crying time over 14 days.
Main Results:
- Infants receiving the new formula showed a significant reduction in colic episodes after 7 days (2.47 vs. 5.99 in control, P < 0.0001).
- This significant difference in crying episodes persisted at day 14 (1.76 in study group vs. 3.32 in control group, P < 0.0001).
- 199 infants completed the study, with 96 in the study group and 103 in the control group.
Conclusions:
- Partially hydrolyzed infant formula supplemented with fructo- and galacto-oligosaccharides (OS) effectively reduces crying episodes in infants with colic.
- The study demonstrates a significant reduction in crying after 7 and 14 days compared to standard formula and simethicone.
- This specialized formula represents a viable option for managing infantile colic.
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.
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