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Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy

NCT ID: NCT02536482

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Cow's Milk Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Amix

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Amix

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children with cow's milk allergy

Exclusion Criteria

* Children without cow's milk allergy
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Ciências Médicas de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role collaborator

Edetec Indústria Alimentícia S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendel O Afonso, Master

Role: STUDY_DIRECTOR

UFMG

References

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Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Reference Type DERIVED
PMID: 33006765 (View on PubMed)

Other Identifiers

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U1111-1173-4156

Identifier Type: -

Identifier Source: org_study_id