Efficacy of a New Thickened Extensively Hydrolyzed Formula

NCT01985607 — Not applicable, Completed, 72 participants, United Pharmaceuticals

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

Registry	NCT01985607, acronym ALLAR
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	72 (Estimated)
Sponsor	United Pharmaceuticals (Industry)
Conditions	Protein Allergy, Cow's Milk Protein Hypersensitivity
Interventions	new extensively hydrolysed formula, Extensively hydrolysed formula (Dietary supplement)
Dates	start 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 in Belgium, Greece, Kuwait, Lebanon, Slovenia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Thickened	Experimental	Dietary Supplement: new extensively hydrolysed formula
Control	Active comparator	Dietary Supplement: Extensively hydrolysed formula

new extensively hydrolysed formula (Dietary supplement)
Extensively hydrolysed formula (Dietary supplement)

+Outcome measures

Primary outcomes

Number of patient dropped out for intolerance [1 month]
Vandenplas' regurgitations score [1 month]

Secondary outcomes

Cow's milk protein hypersensitivity score [1 month]
Growth (weight, height, head circumference) [1 month]
Growth (weight, height, head circumference) [3 months]
Growth (weight, height, head circumference) [6 months]
Number of daily regurgitations [1 month]

+Eligibility

Sex: All, ages: any to 6 Months

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

+Locations (5)

Facility	City	Country
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