Efficacy of a New Thickened Extensively Hydrolyzed Formula (ALLAR)

March 20, 2015 updated by: United Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Dietary supplement: Extensively hydrolysed formula
EXPERIMENTAL: Thickened
Dietary supplement: new extensively hydrolysed formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient dropped out for intolerance
Time Frame: 1 month
1 month
Vandenplas' regurgitations score
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth (weight, height, head circumference)
Time Frame: 1 month
1 month
Growth (weight, height, head circumference)
Time Frame: 3 months
3 months
Growth (weight, height, head circumference)
Time Frame: 6 months
6 months
Cow's milk protein hypersensitivity score
Time Frame: 1 month
1 month
Number of daily regurgitations
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP08-ALLAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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