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Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants

NCT02586558 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-08-28

No results posted yet for this study

Summary

Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.

Conditions

  • Colic

Interventions

OTHER

Experimental Infant formula

Ready-to-feed infant formula to be fed ad libitum

OTHER

Reference group

Ready-to-feed infant formula to be fed ad libitum

Sponsors & Collaborators

Principal Investigators

  • John Cairney, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-08-15
Completion
2019-08-15

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT02586558 on ClinicalTrials.gov