A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

Allergy;Food Clinical Trial

— CHARM  

Official title:

A Prospective, Randomised, Double-blind Controlled Study, to Evaluate the Safety/Hypoallergenicity of a New Rice-based Hydrolysate Formula With New Ingredient for Infants and Children With Diagnosed Cow's Milk Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519827
• Other study ID #: CHARM-01-2020
• Status: Completed
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Dr. Schär AG / SPA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy;Food
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• New Rice-based hydrolysate
A rice-based hydrolysed infant formula with new ingredient
• Amino Acid-based infant formula
An amino acid-based infant formula

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital	Florence
Italy	Spett.le Universita degli Studi di Napoli ''Federico II''	Napoli
Italy	Hospital Infantile Regina Margherita.	Turin
Spain	Hospital Sant Joan de Déu Barcelona 2020,	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Schär AG / SPA

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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