Effect of a Prebiotic on Colic and Crying and Fussing Beh... | NCT02586558

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

NCT02586558

Sponsor

McMaster University

Status

Terminated

Last Update Posted

Aug 28, 2019Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Colic

Interventions

Experimental Infant formula
Reference group

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment issues

Expanded Access Info

Start Date

Dec 13, 2017Actual

Primary Completion Date

Aug 15, 2019Actual

Completion Date

Aug 15, 2019Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 23, 2015

First Posted Date

Oct 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
Abbott Nutrition	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Infant Formula	Active Comparator	Milk-based infant formula with prebiotics	Other: Experimental Infant formula
Reference group	Placebo Comparator	Milk-based infant formula without prebiotics	Other: Reference group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Infant formula	Other	Ready-to-feed infant formula to be fed ad libitum	Experimental Infant Formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Infant crying and fussing behaviour	As assessed by actigraphy and accelerometry	6 weeks
Stool Microbiota		6 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

8 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Cairney, PhD	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David Braley Health Sciences Centre		Hamilton	Ontario	L8P 1H6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003085	Colic

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided