Efficacy of a New Thickened Extensively Hydrolyzed Formula
- Conditions
- Cow's Milk Protein HypersensitivityProtein Allergy
- Registration Number
- NCT01985607
- Lead Sponsor
- United Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- term born infants
- Having a Vandenplas' score of regurgitation of at least 2
- With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test
- Exclusively breast fed infants
- Fed with an extensively hydrolysed formula or amino acid formula
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Vandenplas' regurgitations score 1 month Number of patient dropped out for intolerance 1 month
- Secondary Outcome Measures
Name Time Method Cow's milk protein hypersensitivity score 1 month Growth (weight, height, head circumference) 6 months Number of daily regurgitations 1 month
Trial Locations
- Locations (5)
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
Hippocration Hospital
🇬🇷Thessaloniki, Greece
Faculty of Medicine, Kuwait university
🇰🇼Safat, Kuwait
Pediatricians
🇱🇧Beirut, Lebanon
University Children's Hospital
🇸🇮Ljubljana, Slovenia
Universitair Ziekenhuis Brussel🇧🇪Brussels, Belgium