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

Edetec Indústria Alimentícia S.A.15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cow's Milk Allergy

Interventions

AmixDIETARY_SUPPLEMENT

Treat the children with cow's milk allergy for 5 months.

Eligibility

Sex: ALLMin age: 1 DayMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children with cow's milk allergy Exclusion Criteria: * Children without cow's milk allergy

Outcomes

Primary Outcomes

Study to assess the allergic symptoms, using a questionnaire.

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.

Time frame: 5 months

Secondary Outcomes

Weight assessment, using a digital infant scale

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.

Time frame: 5 months

Height assessment, using an infantometer

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.

Time frame: 5 months

Head circumference, using an infant tape measure

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.

Time frame: 5 months

Data from ClinicalTrials.gov

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