Trial record 1 of 197376 for:    ALL
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Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy

This study has been completed.
Sponsor:
Collaborators:
Faculdade de Ciências Médicas de Minas Gerais
Federal University of Minas Gerais
Information provided by (Responsible Party):
Edetec Indústria Alimentícia S.A.
ClinicalTrials.gov Identifier:
NCT02536482
First received: August 20, 2015
Last updated: August 28, 2015
Last verified: August 2015

August 20, 2015
August 28, 2015
August 2013
February 2015   (final data collection date for primary outcome measure)
Study to assess the allergic symptoms, using a questionnaire. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT02536482 on ClinicalTrials.gov Archive Site
  • Weight assessment, using a digital infant scale [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cow`s Milk Allergy
Dietary Supplement: Amix
Treat the children with cow`s milk allergy for 5 months.
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.
Intervention: Dietary Supplement: Amix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children with cow`s milk allergy

Exclusion Criteria:

  • Children without cow`s milk allergy
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT02536482
U1111-1173-4156
Yes
Edetec Indústria Alimentícia S.A.
Edetec Indústria Alimentícia S.A.
  • Faculdade de Ciências Médicas de Minas Gerais
  • Federal University of Minas Gerais
Study Director: Wendel O Afonso, Master UFMG
Edetec Indústria Alimentícia S.A.
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP