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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Ready-to-feed infant formula to be fed ad libitum
Ready-to-feed infant formula to be fed ad libitum
David Braley Health Sciences Centre
Hamilton, Ontario, Canada
Infant crying and fussing behaviour
As assessed by the Barr Baby Behavior Diary
Time frame: 6 weeks
Infant crying and fussing behaviour
As assessed by actigraphy and accelerometry
Time frame: 6 weeks
Stool Microbiota
Time frame: 6 weeks
Stool calprotectin
Time frame: 6 weeks
Parent satisfaction
As assessed by parent survey
Time frame: 6 weeks
Infant behaviour
As assessed by parent survey
Time frame: 6 weeks
Infant feeding patterns
As assessed by parent survey
Time frame: 6 weeks
Infant stool patterns
As assessed by parent survey
Time frame: 6 weeks
Postnatal depression
As assessed by parent survey
Time frame: 6 weeks
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