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

NCT ID: NCT03557671

Last Updated: 2020-11-04

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

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2020-09-21

Brief Summary

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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.

Detailed Description

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The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo.

The second part of the trial consists in an open phase during which all infants will be fed with the study formula.

Conditions

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Cow Milk Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRHF - Placebo

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Group Type EXPERIMENTAL

rice formula

Intervention Type DIETARY_SUPPLEMENT

new rice based thickened formula

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo - TRHF

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Group Type PLACEBO_COMPARATOR

rice formula

Intervention Type DIETARY_SUPPLEMENT

new rice based thickened formula

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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rice formula

new rice based thickened formula

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
* free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
* whose parents signed the informed consent

Exclusion Criteria

* mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
Minimum Eligible Age

1 Month

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Statitec

INDUSTRY

Sponsor Role collaborator

United Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto Berni Canani

Role: STUDY_DIRECTOR

University Federico II

Locations

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CHR Namur

Namur, , Belgium

Site Status

Hôpital Saint Vincent de Paul - GHICL

Lille, , France

Site Status

Hopital Trousseau

Paris, , France

Site Status

University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Belgium France Italy

Other Identifiers

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UP2017-Promyce

Identifier Type: -

Identifier Source: org_study_id