Back to resultsEffect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants (CRI)
Primary Purpose
Colic
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Experimental Infant formula
Reference group
Sponsored by
About this trial
This is an interventional treatment trial for Colic
Eligibility Criteria
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
Sites / Locations
- David Braley Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental Infant Formula
Reference group
Arm Description
Milk-based infant formula with prebiotics
Milk-based infant formula without prebiotics
Outcomes
Primary Outcome Measures
Infant crying and fussing behaviour
As assessed by the Barr Baby Behavior Diary
Secondary Outcome Measures
Infant crying and fussing behaviour
As assessed by actigraphy and accelerometry
Stool Microbiota
Stool calprotectin
Parent satisfaction
As assessed by parent survey
Infant behaviour
As assessed by parent survey
Infant feeding patterns
As assessed by parent survey
Infant stool patterns
As assessed by parent survey
Postnatal depression
As assessed by parent survey
Full Information
NCT ID
NCT02586558
First Posted
October 23, 2015
Last Updated
August 22, 2019
Sponsor
McMaster University
Collaborators
Abbott Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT02586558
Brief Title
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
Acronym
CRI
Official Title
Effect of Prebiotic on Colic and Crying and Fussing Behaviour in Infants CRI Study: Colic Relief Initiative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment issues
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Abbott Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Infant Formula
Arm Type
Active Comparator
Arm Description
Milk-based infant formula with prebiotics
Arm Title
Reference group
Arm Type
Placebo Comparator
Arm Description
Milk-based infant formula without prebiotics
Intervention Type
Other
Intervention Name(s)
Experimental Infant formula
Intervention Description
Ready-to-feed infant formula to be fed ad libitum
Intervention Type
Other
Intervention Name(s)
Reference group
Intervention Description
Ready-to-feed infant formula to be fed ad libitum
Primary Outcome Measure Information:
Title
Infant crying and fussing behaviour
Description
As assessed by the Barr Baby Behavior Diary
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Infant crying and fussing behaviour
Description
As assessed by actigraphy and accelerometry
Time Frame
6 weeks
Title
Stool Microbiota
Time Frame
6 weeks
Title
Stool calprotectin
Time Frame
6 weeks
Title
Parent satisfaction
Description
As assessed by parent survey
Time Frame
6 weeks
Title
Infant behaviour
Description
As assessed by parent survey
Time Frame
6 weeks
Title
Infant feeding patterns
Description
As assessed by parent survey
Time Frame
6 weeks
Title
Infant stool patterns
Description
As assessed by parent survey
Time Frame
6 weeks
Title
Postnatal depression
Description
As assessed by parent survey
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cairney, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Braley Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 1H6
Country
Canada
12. IPD Sharing Statement
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Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
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