NCT01721850

Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: HiPP GmbH & Co. Vertrieb KG · Industry
• Sex: All
• Age: 15 Days – 60 Days
• Healthy volunteers: Accepted

Summary

The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic. Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
OTHER	control formula	commercial stage 1 infant formula
OTHER	intervention formula 1	infant formula with hydrolyzed protein (type I) and pre- and probiotics
OTHER	intervention formula 2	infant formula with hydrolyzed protein (type II) and pre- and probiotics

Timeline

• Start date: 2011-12-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2012-11-06
• Last updated: 2022-01-20

Locations

18 sites across 2 countries: Germany, Italy