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Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

NCT02414243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-01-18

Study results available
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Summary

This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged\< 12 years with documented cow's milk protein allergy (CMPA).

Conditions

  • Cow's Milk Allergy

Interventions

OTHER

New Amino Acid formula

Ordesa's Amino-Acid based Infant Formula

OTHER

Commercially available Amino Acid Formula

Commercially available Amino Acid Formula

Sponsors & Collaborators

  • OPBG Clinical & Research Services S.R.L.

    collaborator UNKNOWN

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Claudia Banzato, MD · Azienda Ospedaliera Universitaria Integrata, Verona, Italy

  • Maria Pedrosa, MD · Hospital Universitario La Paz

  • Elena Alonso, MD · Hospital General Universitario Gregorio Marañón, Madrid, Spain

  • Montserrat Bosque, MD · Hospital Universitario Parc Taulí Sabadell, Barcelona, Spain

  • Anna Mª Plaza, MD · Hospital Sant Joan de Déu, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-30
Completion
2016-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414243 on ClinicalTrials.gov