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Efficacy of a New Thickened Extensively Hydrolyzed Formula (ALLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01985607
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
United Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Protein Allergy Cow's Milk Protein Hypersensitivity Dietary Supplement: new extensively hydrolysed formula Dietary Supplement: Extensively hydrolysed formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
Study Start Date : February 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Thickened Dietary Supplement: new extensively hydrolysed formula
Active Comparator: Control Dietary Supplement: Extensively hydrolysed formula



Primary Outcome Measures :
  1. Number of patient dropped out for intolerance [ Time Frame: 1 month ]
  2. Vandenplas' regurgitations score [ Time Frame: 1 month ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985607


Locations
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Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Greece
Hippocration Hospital
Thessaloniki, Greece
Kuwait
Faculty of Medicine, Kuwait university
Safat, Kuwait
Lebanon
Pediatricians
Beirut, Lebanon
Slovenia
University Children's Hospital
Ljubljana, Slovenia
Sponsors and Collaborators
United Pharmaceuticals
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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01985607    
Other Study ID Numbers: UP08-ALLAR
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases