Colic
Conditions
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.
Interventions
Ready-to-feed infant formula to be fed ad libitum
OTHERReference group
Ready-to-feed infant formula to be fed ad libitum
Sponsors
Abbott Nutrition
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 8 Weeks
Healthy volunteers
No
Inclusion criteria
* Healthy, term infant from a singleton birth (=\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
Exclusion criteria
* Infants with known genetic syndromes; birth weight (\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant crying and fussing behaviour | 6 weeks | As assessed by the Barr Baby Behavior Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Microbiota | 6 weeks | — |
| Stool calprotectin | 6 weeks | — |
| Parent satisfaction | 6 weeks | As assessed by parent survey |
| Infant crying and fussing behaviour | 6 weeks | As assessed by actigraphy and accelerometry |
| Infant feeding patterns | 6 weeks | As assessed by parent survey |
| Infant stool patterns | 6 weeks | As assessed by parent survey |
| Postnatal depression | 6 weeks | As assessed by parent survey |
| Infant behaviour | 6 weeks | As assessed by parent survey |
Countries
Canada
Outcome results
None listed