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

Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy

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

Study Overview

• Status: Completed
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Dietary supplement: Amix

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with cow's milk allergy

Exclusion Criteria:

• Children without cow's milk allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Amix; Treat the children with cow's milk allergy for 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	5 months

Collaborators and Investigators

• Sponsor: Edetec Indústria Alimentícia S.A.
• Collaborators: Federal University of Minas Gerais; Faculdade de Ciências Médicas de Minas Gerais
• Investigators: Study Director: Wendel O Afonso, Master, UFMG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: U1111-1173-4156