Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cow's Milk Allergy
- Sponsor
- Edetec Indústria Alimentícia S.A.
- Enrollment
- 15
- Primary Endpoint
- Study to assess the allergic symptoms, using a questionnaire.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children with cow's milk allergy
Exclusion Criteria
- •Children without cow's milk allergy
Outcomes
Primary Outcomes
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
- Weight assessment, using a digital infant scale(5 months)
- Height assessment, using an infantometer(5 months)
- Head circumference, using an infant tape measure(5 months)