search
Back to results

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
Edetec Indústria Alimentícia S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow's Milk Allergy

Eligibility Criteria

1 Day - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

    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
    search

    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

    We'll reach out to this number within 24 hrs