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NCT01998074 Clinical Trial

Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy

Food Sensitivity Clinical Trial

— Paradice  

Official title:
Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01998074
Other study ID # UP2010-Paradice
Secondary ID BUN 143201010095
Status Completed
Phase N/A
First received November 22, 2013
Last updated November 27, 2013

Study information
Verified date November 2013
Source United Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des Médecins
Study type Interventional

Clinical Trial Summary

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- Infants between 2 weeks and 6 months old

- In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

Exclusion Criteria:

- Exclusively breast fed infants

- Preterm infants

- Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.

- Infants fed an amino acid based formula

- Infants who had an anaphylactic reaction in the past

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• extensively hydrolyzed rice protein formula

Locations
Country Name City State
Belgium Universitair Ziekenhuis Brussel

Sponsors (1)
Lead Sponsor Collaborator
United Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score at 4 weeks
Secondary Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score at 3 months
Secondary Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score at 6 months
Secondary Growth (weight, height, head circumference) 1 month
Secondary Growth (weight, height, head circumference) 3 months
Secondary Growth (weight, height, head circumference) 6 months
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