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

Phase 2

Completed

• Conditions: Cow's Milk Allergy
• Interventions: Dietary Supplement: Amix

• Registration Number: NCT02536482
• Lead Sponsor: Edetec Indústria Alimentícia S.A.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-28
• Last Update Submitted: 2015-08-28
• Study First Posted: 2015-08-31
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Children with cow's milk allergy

Exclusion Criteria

• Children without cow's milk allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amix	Amix	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.

Primary Outcome Measures

Name	Time	Method
Study to assess the allergic symptoms, using a questionnaire.	5 months	The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered "yes" or "no" according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission.

Secondary Outcome Measures

Name	Time	Method
Weight assessment, using a digital infant scale	5 months	Every medical appointment the doctor measured the weight, by using a digital infant scale. The values were plotted in the software WHO Anthro. A curve weight/age was obtained and the children's weight were compared to the standard population's weight, by the z-score.
Height assessment, using an infantometer	5 months	Every medical appointment the doctor measured the height by using a digital infant scale. The values were plotted in the software Anthro. A curve height/age was obtained and the children's height were compared to the standard population's height, by the z-score.
Head circumference, using an infant tape measure	5 months	Every medical appointment the doctor measured the head circumference by using a infant tape measure. The values were plotted in the software Anthro. A curve head circumference/age was obtained and the children's head circumference were compared to the standard population's head circumference, by the z-score.