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

Not Applicable

Terminated

• Conditions: Colic
• Interventions: Other: Reference group; Other: Experimental Infant formula

• Registration Number: NCT02586558
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Study Start: 2017-12-13
• Status Verified: 2019-08
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference group	Reference group	Milk-based infant formula without prebiotics
Experimental Infant Formula	Experimental Infant formula	Milk-based infant formula with prebiotics

Primary Outcome Measures

Name	Time	Method
Infant crying and fussing behaviour	6 weeks	As assessed by the Barr Baby Behavior Diary

Secondary Outcome Measures

Name	Time	Method
Stool Microbiota	6 weeks
Stool calprotectin	6 weeks
Parent satisfaction	6 weeks	As assessed by parent survey
Infant behaviour	6 weeks	As assessed by parent survey
Infant crying and fussing behaviour	6 weeks	As assessed by actigraphy and accelerometry
Postnatal depression	6 weeks	As assessed by parent survey
Infant feeding patterns	6 weeks	As assessed by parent survey
Infant stool patterns	6 weeks	As assessed by parent survey

Trial Locations

Locations (1)

David Braley Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada