Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy

Edetec Indústria Alimentícia

Status and phase: Completed; Phase 2

Conditions: Cow's Milk Allergy

Treatments: Dietary Supplement: Amix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02536482

U1111-1173-4156

Details and patient eligibility

About

It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.

Full description

In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.

Enrollment: 15 patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with cow's milk allergy

Exclusion criteria

• Children without cow's milk allergy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Amix

Experimental group

Description:

Dietary supplement. The formula is based in free amino-acid to treat children with cow's milk allergy. The children should have a minimum consumption of 400 mL, daily.

Treatment:

Dietary Supplement: Amix