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

NCT02586558 | Terminated DMC

• 1 other identifier: INCH-681
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Colic

Outcome Measures

Primary Outcomes (1)

• Infant crying and fussing behaviour

  As assessed by the Barr Baby Behavior Diary

  6 weeks

Secondary Outcomes (8)

• Infant crying and fussing behaviour

  6 weeks

• Stool Microbiota

  6 weeks

• Stool calprotectin

  6 weeks

• Parent satisfaction

  6 weeks

• Infant behaviour

  6 weeks

Study Arms (2)

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

Experimental Infant formula OTHER

Ready-to-feed infant formula to be fed ad libitum

Experimental Infant Formula

Reference group OTHER

Ready-to-feed infant formula to be fed ad libitum

Reference group

Eligibility Criteria

• Age: 2 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Abbott Nutrition: collaborator

Study Sites (1)

David Braley Health Sciences Centre

Hamilton, Ontario, L8P 1H6, Canada

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John Cairney, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: December 13, 2017
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CA (1)