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A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

NCT ID: NCT04519827

Last Updated: 2023-12-08

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2023-11-29

Brief Summary

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Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.

Detailed Description

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A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).

Conditions

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Allergy;Food

Keywords

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Cow's Milk Protein Allergy (CMPA) Cow's Milk Allergy (CMA) CHILDREN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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New Rice-based hydrolysate

The TEST formula is a new Rice-based hydrolysate with new ingredient.

Group Type EXPERIMENTAL

New Rice-based hydrolysate

Intervention Type OTHER

A rice-based hydrolysed infant formula with new ingredient

Amino-acid based formula

The PLACEBO is an Amino-acid based formula.

Group Type PLACEBO_COMPARATOR

Amino Acid-based infant formula

Intervention Type OTHER

An amino acid-based infant formula

Interventions

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New Rice-based hydrolysate

A rice-based hydrolysed infant formula with new ingredient

Intervention Type OTHER

Amino Acid-based infant formula

An amino acid-based infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Children \<10 yrs of age
2. Proven IgE-mediated CMA
3. \>2500g at birth
4. \> 37 weeks gestation
5. Written informed consent provided by parent(s)/guardian

Exclusion Criteria

1. Infants/children with severe concurrent illness (other than food allergy/CMA)
2. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
3. Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study
4. Current participation in OIT to Cow's Milk
5. Diagnosis of anaphylaxis to Cow's Milk
6. Diagnosis of rice allergy
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Schär AG / SPA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meyer Children's Hospital

Florence, , Italy

Site Status

Spett.le Universita degli Studi di Napoli ''Federico II''

Napoli, , Italy

Site Status

Hospital Infantile Regina Margherita.

Turin, , Italy

Site Status

Hospital Sant Joan de Déu Barcelona 2020,

Barcelona, , Spain

Site Status

Countries

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Italy Spain

Other Identifiers

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CHARM-01-2020

Identifier Type: -

Identifier Source: org_study_id