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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

Primary Purpose

Cow Milk Allergy

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Amino acid based formula

About this trial

This is an interventional treatment trial for Cow Milk Allergy focused on measuring Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity

Eligibility Criteria

2 Weeks - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Necker Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Thickened Amino acid based formula

Amino acid based formula

Arm Description

Outcomes

Primary Outcome Measures

Number of withdrawal for intolerance

Secondary Outcome Measures

Full Information

NCT ID

NCT01940068

First Posted

September 6, 2013

Last Updated

March 20, 2015

Sponsor

United Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01940068

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 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

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cow Milk Allergy

Keywords

Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

New Thickened Amino acid based formula

Arm Type

Experimental

Arm Title

Amino acid based formula

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Amino acid based formula

Primary Outcome Measure Information:

Title

Number of withdrawal for intolerance

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Weeks

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Necker Children's Hospital

City

Paris

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

33006765

Citation

Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Results Reference

derived

PubMed Identifier

25844709

Citation

Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guenard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.

Results Reference

derived

PubMed Identifier

25446768

Citation

Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guenard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.

Results Reference

derived

Learn more about this trial

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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