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Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

NCT03557671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-11-04

No results posted yet for this study

Summary

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

Conditions

  • Cow Milk Allergy

Interventions

DIETARY_SUPPLEMENT

rice formula

new rice based thickened formula

DIETARY_SUPPLEMENT

placebo

formula previously tolerated by the subject - only for the 1st part of the study

Sponsors & Collaborators

  • Statitec

    collaborator INDUSTRY

  • United Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Roberto Berni Canani · University Federico II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2020-09-21
Completion
2020-09-21

Countries

  • Belgium
  • France
  • 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 NCT03557671 on ClinicalTrials.gov