Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02536482
Enrollment
15
Registered
2015-08-31
Start date
2013-08-31
Completion date
2015-06-30
Last updated
2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy

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.

Interventions

DIETARY_SUPPLEMENTAmix

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

Sponsors

Faculdade de Ciências Médicas de Minas Gerais
CollaboratorOTHER
Federal University of Minas Gerais
CollaboratorOTHER
Edetec Indústria Alimentícia S.A.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No

Inclusion criteria

* Children with cow's milk allergy

Exclusion criteria

* Children without cow's milk allergy

Design outcomes

Primary

MeasureTime frameDescription
Study to assess the allergic symptoms, using a questionnaire.5 monthsThe 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

MeasureTime frameDescription
Weight assessment, using a digital infant scale5 monthsEvery 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 infantometer5 monthsEvery 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 measure5 monthsEvery 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026