A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

NCT04519827 | Completed

• 1 other identifier: CHARM-01-2020
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Allergy;Food

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hypoallergenicity

  90% of children tolerate the TEST formula with a 95% CI - using the double blind placebo controlled food challenge and open challenge (Test vs. placebo).

  7 days open challenge

Study Arms (2)

New Rice-based hydrolysate

EXPERIMENTAL

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

Other: New Rice-based hydrolysate

Amino-acid based formula

PLACEBO COMPARATOR

The PLACEBO is an Amino-acid based formula.

Other: Amino Acid-based infant formula

Interventions

New Rice-based hydrolysate OTHER

A rice-based hydrolysed infant formula with new ingredient

New Rice-based hydrolysate

Amino Acid-based infant formula OTHER

An amino acid-based infant formula

Amino-acid based formula

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead

Study Sites (4)

Meyer Children's Hospital

Florence, 50139, Italy

Location

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

Napoli, 80131, Italy

Location

Hospital Infantile Regina Margherita.

Turin, 10126, Italy

Location

Hospital Sant Joan de Déu Barcelona 2020,

Barcelona, 08950 Esplugues de Llobregat,, Spain

Location

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: May 21, 2020
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (3)