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Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy

NCT02405923 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2019-07-18

No results posted yet for this study

Summary

This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

Conditions

  • Cow's Milk Allergy

Interventions

OTHER

HRF

The subject will take the formula for a period of 12 months.

OTHER

eHF

The subject will take the formula for a period of 12 months.

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Mireia Mireia, MD · Laboratorios Ordesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2019-04-11
Completion
2019-04-11

Countries

  • France
  • Spain

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 NCT02405923 on ClinicalTrials.gov