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Efficacy of a New Thickened Extensively Hydrolyzed Formula

Not Applicable
Completed
Conditions
Cow's Milk Protein Hypersensitivity
Protein 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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
NameTimeMethod
Vandenplas' regurgitations score1 month
Number of patient dropped out for intolerance1 month
Secondary Outcome Measures
NameTimeMethod
Cow's milk protein hypersensitivity score1 month
Growth (weight, height, head circumference)6 months
Number of daily regurgitations1 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

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