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

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

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 Overview

• Status: Terminated
• Conditions: Colic
• Intervention / Treatment: Other: Experimental Infant formula; Other: Reference group

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P 1H6
      • David Braley Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: INCH-681

Drug and device information, study documents

• 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