Cow`s Milk Allergy Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | June 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 5 Years |
| Eligibility |
Inclusion Criteria: - Children with cow`s milk allergy Exclusion Criteria: - Children without cow`s milk allergy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Edetec Indústria Alimentícia S.A. | Faculdade de Ciências Médicas de Minas Gerais, Federal University of Minas Gerais |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |