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Efficacy of a New Thickened Extensively Hydrolyzed Formula (ALLAR)

Primary Purpose

Protein Allergy, Cow's Milk Protein Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
new extensively hydrolysed formula
Extensively hydrolysed formula
Sponsored by
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein Allergy

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel
  • Hippocration Hospital
  • Faculty of Medicine, Kuwait university
  • Pediatricians
  • University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thickened

Control

Arm Description

Outcomes

Primary Outcome Measures

Number of patient dropped out for intolerance
Vandenplas' regurgitations score

Secondary Outcome Measures

Cow's milk protein hypersensitivity score
Growth (weight, height, head circumference)
Growth (weight, height, head circumference)
Growth (weight, height, head circumference)
Number of daily regurgitations

Full Information

First Posted
November 8, 2013
Last Updated
March 20, 2015
Sponsor
United Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01985607
Brief Title
Efficacy of a New Thickened Extensively Hydrolyzed Formula
Acronym
ALLAR
Official Title
Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Allergy, Cow's Milk Protein Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thickened
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
new extensively hydrolysed formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Extensively hydrolysed formula
Primary Outcome Measure Information:
Title
Number of patient dropped out for intolerance
Time Frame
1 month
Title
Vandenplas' regurgitations score
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cow's milk protein hypersensitivity score
Time Frame
1 month
Title
Growth (weight, height, head circumference)
Time Frame
1 month
Title
Growth (weight, height, head circumference)
Time Frame
3 months
Title
Growth (weight, height, head circumference)
Time Frame
6 months
Title
Number of daily regurgitations
Time Frame
1 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Hippocration Hospital
City
Thessaloniki
Country
Greece
Facility Name
Faculty of Medicine, Kuwait university
City
Safat
Country
Kuwait
Facility Name
Pediatricians
City
Beirut
Country
Lebanon
Facility Name
University Children's Hospital
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

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Efficacy of a New Thickened Extensively Hydrolyzed Formula

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