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A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

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ClinicalTrials.gov Identifier: NCT01940068
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
United Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: Amino acid based formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Study Start Date : March 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: New Thickened Amino acid based formula Dietary Supplement: Amino acid based formula
Active Comparator: Amino acid based formula Dietary Supplement: Amino acid based formula



Primary Outcome Measures :
  1. Number of withdrawal for intolerance [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 18 months old
  • with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination
  • still symptomatic while fed an extensively hydrolysed formula

Exclusion Criteria:

  • Exclusively breast fed infants
  • non allergic digestive enteropathy

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): NCT01940068


Locations
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France
Necker Children's Hospital
Paris, France
Sponsors and Collaborators
United Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01940068    
Other Study ID Numbers: PRO-UP05-E1
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by United Pharmaceuticals:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Additional relevant MeSH terms:
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Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases