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Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic

NCT02813772 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2016-09-08

No results posted yet for this study

Summary

Infant colic (IC) is responsible of 25% of pediatric consultation in the first 3-4 months of life affecting from 5% to 30% of infants between 2 weeks and 3 months of life (3, 4). The variability in the prevalence of IC reported by the several studies depends on different criteria used to define IC.The etiology of IC remains still unclear. Recently, the composition of intestinal microbiome has been addressed as an independent risk factor for IC. There are no uniform criteria for a specific therapeutic approach of IC. Based on these conclusions the objectives of our study are: to determine whether the administration of a partially hydrolyzed formula (pHF) with reduced lactose content and Lactobacillus reuteri, is beneficial in IC in reducing the infant crying duration and in prolonging the duration of sleeping period

Conditions

  • Infant Colics

Interventions

DIETARY_SUPPLEMENT

Milk formula NAN Sensitive, Nestle

Infants randomized to group 1 will receive the milk formula NAN Sensitive, Nestle for a period of 4 weeks.

DIETARY_SUPPLEMENT

Milk formula Optipro, Nestle

Infants randomized to group 1 will receive the milk formula NAN Optipro, Nestle for a period of 4 weeks.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813772 on ClinicalTrials.gov