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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01940068

Enrollment

Registered

2013-09-11

Start date

2011-03-31

Completion date

2013-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow Milk Allergy

Keywords

Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity

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;

Interventions

DIETARY_SUPPLEMENTAmino acid based formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 18 Months

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

Design outcomes

Primary

Measure	Time frame
Number of withdrawal for intolerance	1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026