A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula (CHARM)

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

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.

Study Overview

• Status: Completed
• Conditions: Allergy;Food
• Intervention / Treatment: Other: New Rice-based hydrolysate; Other: Amino Acid-based infant formula

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Meraner; Phone Number: +39 0473 293 648; Email: Marion.Meraner@drschar-medical.com

Study Locations

• Italy
  • Florence, Italy, 50139
    • Meyer Children's Hospital
  • Napoli, Italy, 80131
    • Spett.le Universita degli Studi di Napoli ''Federico II''
  • Turin, Italy, 10126
    • Hospital Infantile Regina Margherita.
• Spain
  • Barcelona, Spain, 08950 Esplugues de Llobregat,
    • Hospital Sant Joan de Déu Barcelona 2020,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Rice-based hydrolysate; The TEST formula is a new Rice-based hydrolysate with new ingredient.	Other: New Rice-based hydrolysate; A rice-based hydrolysed infant formula with new ingredient
Placebo Comparator: Amino-acid based formula; The PLACEBO is an Amino-acid based formula.	Other: Amino Acid-based infant formula; An amino acid-based infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Schär AG / SPA

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cow's Milk Protein Allergy (CMPA); Cow's Milk Allergy (CMA); CHILDREN
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: CHARM-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No