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

Colic Clinical Trial

— CRI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02586558
• Other study ID #: INCH-681
• Status: Terminated
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Colic

Intervention

Other:
• Experimental Infant formula
Ready-to-feed infant formula to be fed ad libitum
• Reference group
Ready-to-feed infant formula to be fed ad libitum

Locations

Country	Name	City	State
Canada	David Braley Health Sciences Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Abbott Nutrition

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant crying and fussing behaviour	As assessed by the Barr Baby Behavior Diary	6 weeks
Secondary	Infant crying and fussing behaviour	As assessed by actigraphy and accelerometry	6 weeks
Secondary	Stool Microbiota		6 weeks
Secondary	Stool calprotectin		6 weeks
Secondary	Parent satisfaction	As assessed by parent survey	6 weeks
Secondary	Infant behaviour	As assessed by parent survey	6 weeks
Secondary	Infant feeding patterns	As assessed by parent survey	6 weeks
Secondary	Infant stool patterns	As assessed by parent survey	6 weeks
Secondary	Postnatal depression	As assessed by parent survey	6 weeks