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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colic

Intervention / Treatment
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* Other: Experimental Infant formula
* Other: Reference group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Infant Formula<br>Milk-based infant formula with prebiotics | Other: Experimental Infant formula<br>* Ready-to-feed infant formula to be fed ad libitum<br>|
| Placebo Comparator: Reference group<br>Milk-based infant formula without prebiotics | Other: Reference group<br>* Ready-to-feed infant formula to be fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant crying and fussing behaviour | As assessed by the Barr Baby Behavior Diary | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant crying and fussing behaviour | As assessed by actigraphy and accelerometry | 6 weeks | 
| Stool Microbiota |  | 6 weeks | 
| Stool calprotectin |  | 6 weeks | 
| Parent satisfaction | As assessed by parent survey | 6 weeks | 
| Infant behaviour | As assessed by parent survey | 6 weeks | 
| Infant feeding patterns | As assessed by parent survey | 6 weeks | 
| Infant stool patterns | As assessed by parent survey | 6 weeks | 
| Postnatal depression | As assessed by parent survey | 6 weeks |