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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study

Brief 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.

Detailed Summary:
Sponsor: McMaster University

Current Primary Outcome: Infant crying and fussing behaviour [ Time Frame: 6 weeks ]

As assessed by the Barr Baby Behavior Diary


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infant crying and fussing behaviour [ Time Frame: 6 weeks ]
    As assessed by actigraphy and accelerometry
  • Stool Microbiota [ Time Frame: 6 weeks ]
  • Stool calprotectin [ Time Frame: 6 weeks ]
  • Parent satisfaction [ Time Frame: 6 weeks ]
    As assessed by parent survey
  • Infant behaviour [ Time Frame: 6 weeks ]
    As assessed by parent survey
  • Infant feeding patterns [ Time Frame: 6 weeks ]
    As assessed by parent survey
  • Infant stool patterns [ Time Frame: 6 weeks ]
    As assessed by parent survey
  • Postnatal depression [ Time Frame: 6 weeks ]
    As assessed by parent survey


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: October 23, 2015
Date Started: January 2016
Date Completion: June 2017
Last Updated: October 23, 2015
Last Verified: October 2015