NCT01143233

Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: HiPP GmbH & Co. Vertrieb KG · Industry
• Sex: All
• Age: 1 Day – 27 Days
• Healthy volunteers: Accepted

Summary

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants. Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life. 4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

Detailed description

View Section Brief Summary

Conditions

• Disturbance of Growth

Interventions

Type	Name	Description
OTHER	control formula	infants are fed a commercial hydrolyzed formula
OTHER	intervention formula 1	formula has hydrolysed protein and a different protein content
OTHER	intervention formula 2	formula has hydrolysed protein, different protein content and pro- and prebiotics
OTHER	intervention formula 3	formula has hydrolysed protein, different protein content and pro- and prebiotics

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-07-01
• Completion: 2017-08-01
• First posted: 2010-06-14
• Last updated: 2017-11-30

Locations

5 sites across 3 countries: Austria, Germany, Serbia