NCT03329222

An Infant Formula Trial on Dietary Management of Infantile Colic

A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. · Industry
• Sex: All
• Age: 21 Days – 56 Days
• Healthy volunteers: Not accepted

Summary

A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.

Detailed description

A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic. The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic. The various time points of the outcome are: V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)

Conditions

• Infantile Colic

Interventions

Type	Name	Description
OTHER	Specific hydrolysed proteins	An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
OTHER	Standard cow's milk with prebiotics mixture	Standard cow's milk with prebiotics mixture

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-07-03
• Completion: 2018-07-03
• First posted: 2017-11-01
• Last updated: 2018-09-10

Locations

2 sites across 2 countries: Singapore, Thailand