NCT02405923

Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy

Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Laboratorios Ordesa · Industry
• Sex: All
• Age: 10 Months
• Healthy volunteers: Not accepted

Summary

This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

Detailed description

The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.

Conditions

• Cow's Milk Allergy

Interventions

Type	Name	Description
OTHER	HRF	The subject will take the formula for a period of 12 months.
OTHER	eHF	The subject will take the formula for a period of 12 months.

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2015-04-01
• Last updated: 2019-07-18

Locations

5 sites across 2 countries: France, Spain