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Completed

NCT Number: NCT02536482

Free Amino Acid-based Formula to Treat Children 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.

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Key information

Conditions

Cow's Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with cow's milk allergy

Exclusion criteria

  • Children without cow's milk allergy

Treatment and study plan

Amix

Dietary Supplement

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

Primary outcomes

  1. Study to assess the allergic symptoms, using a questionnaire.

    Time frame: 5 months

    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 outcomes

  1. Weight assessment, using a digital infant scale

    Time frame: 5 months

    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.

  2. Height assessment, using an infantometer

    Time frame: 5 months

    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.

  3. Head circumference, using an infant tape measure

    Time frame: 5 months

    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.

Sponsors and collaborators

Lead sponsor

Edetec Indústria Alimentícia S.A.

Industry

Collaborators

  • Faculdade de Ciências Médicas de Minas Gerais
  • Federal University of Minas Gerais

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2015
Registry last updated
Aug 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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