NCT01985607

Efficacy of a New Thickened Extensively Hydrolyzed Formula

Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: United Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate . This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.

Conditions

• Protein Allergy
• Cow's Milk Protein Hypersensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	new extensively hydrolysed formula
DIETARY_SUPPLEMENT	Extensively hydrolysed formula

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2013-11-15
• Last updated: 2015-03-24

Locations

5 sites across 5 countries: Belgium, Greece, Kuwait, Lebanon, Slovenia