Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
Primary Purpose
Cow's Milk Allergy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Amix
Sponsored by
About this trial
This is an interventional treatment trial for Cow's Milk Allergy
Eligibility Criteria
Inclusion Criteria:
- Children with cow's milk allergy
Exclusion Criteria:
- Children without cow's milk allergy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amix
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02536482
First Posted
August 20, 2015
Last Updated
August 28, 2015
Sponsor
Edetec Indústria Alimentícia S.A.
Collaborators
Faculdade de Ciências Médicas de Minas Gerais, Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02536482
Brief Title
Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
Official Title
Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edetec Indústria Alimentícia S.A.
Collaborators
Faculdade de Ciências Médicas de Minas Gerais, Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amix
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Amix
Intervention Description
Treat the children with cow's milk allergy for 5 months.
Primary Outcome Measure Information:
Title
Study to assess the allergic symptoms, using a questionnaire.
Description
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 Outcome Measure Information:
Title
Weight assessment, using a digital infant scale
Description
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
Title
Height assessment, using an infantometer
Description
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
Title
Head circumference, using an infant tape measure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with cow's milk allergy
Exclusion Criteria:
Children without cow's milk allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendel O Afonso, Master
Organizational Affiliation
UFMG
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
33006765
Citation
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.
Results Reference
derived
Learn more about this trial
Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
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