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OpenTrials
Completed

NCT Number: NCT01985607

Efficacy of a New Thickened Extensively Hydrolyzed Formula

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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Key information

Conditions

Protein Allergy Cow's Milk Protein Hypersensitivity

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

new extensively hydrolysed formula

Dietary Supplement

Extensively hydrolysed formula

Dietary Supplement

Primary outcomes

  1. Number of patient dropped out for intolerance

    Time frame: 1 month

  2. Vandenplas' regurgitations score

    Time frame: 1 month

Secondary outcomes

  1. Cow's milk protein hypersensitivity score

    Time frame: 1 month

  2. Growth (weight, height, head circumference)

    Time frame: 1 month

  3. Growth (weight, height, head circumference)

    Time frame: 3 months

  4. Growth (weight, height, head circumference)

    Time frame: 6 months

  5. Number of daily regurgitations

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ALLAR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2013
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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