Efficacy of a New Thickened Extensively Hydrolyzed Formula

Protein Allergy Clinical Trial

— ALLAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985607
• Other study ID #: UP08-ALLAR
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: March 20, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeGreece: Ethics CommitteeKuwait: Joint Committee for the Protection of Human Subjects in ResearchSlovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cow's Milk Protein Hypersensitivity
• Hypersensitivity
• Protein Allergy

Intervention

Dietary Supplement:
• new extensively hydrolysed formula

• Extensively hydrolysed formula

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels
Greece	Hippocration Hospital	Thessaloniki
Kuwait	Faculty of Medicine, Kuwait university	Safat
Lebanon	Pediatricians	Beirut
Slovenia	University Children's Hospital	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
United Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Greece,  Kuwait,  Lebanon,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient dropped out for intolerance		1 month	Yes
Primary	Vandenplas' regurgitations score		1 month	No
Secondary	Cow's milk protein hypersensitivity score		1 month	No
Secondary	Growth (weight, height, head circumference)		1 month	No
Secondary	Growth (weight, height, head circumference)		3 months	No
Secondary	Growth (weight, height, head circumference)		6 months	No
Secondary	Number of daily regurgitations		1 month	No