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Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old

NCT02430831 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-30

No results posted yet for this study

Summary

Study type:

Randomized controlled trial with two parallel arms Objectives

Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as

1. the number of "responders" or the "treatment success" (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time \>50% in 3 weeks. (day 1 to day 21 of the study)
2. maternal depression and family functioning scoring

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

Nidina

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Antonio Di Mauro

    collaborator UNKNOWN

  • Ruggiero Francavilla

    collaborator UNKNOWN

  • Lorenzo Trovè

    collaborator UNKNOWN

  • University of Bari

    lead OTHER

Principal Investigators

  • Flavia Indrio, MD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

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 NCT02430831 on ClinicalTrials.gov