A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula (CHARM)
Primary Purpose
Allergy;Food
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
New Rice-based hydrolysate
Amino Acid-based infant formula
Sponsored by
About this trial
This is an interventional other trial for Allergy;Food focused on measuring Cow's Milk Protein Allergy (CMPA), Cow's Milk Allergy (CMA), CHILDREN
Eligibility Criteria
Inclusion Criteria:
- Children <10 yrs of age
- Proven IgE-mediated CMA
- >2500g at birth
- > 37 weeks gestation
- Written informed consent provided by parent(s)/guardian
Exclusion Criteria:
- 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
Sites / Locations
- Meyer Children's Hospital
- Hospital Infantile Regina Margherita.Recruiting
- Hospital Sant Joan de Déu Barcelona 2020,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
New Rice-based hydrolysate
Amino-acid based formula
Arm Description
The TEST formula is a new Rice-based hydrolysate with new ingredient.
The PLACEBO is an Amino-acid based formula.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04519827
Brief Title
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Schär AG / SPA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy;Food
Keywords
Cow's Milk Protein Allergy (CMPA), Cow's Milk Allergy (CMA), CHILDREN
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New Rice-based hydrolysate
Arm Type
Experimental
Arm Description
The TEST formula is a new Rice-based hydrolysate with new ingredient.
Arm Title
Amino-acid based formula
Arm Type
Placebo Comparator
Arm Description
The PLACEBO is an Amino-acid based formula.
Intervention Type
Other
Intervention Name(s)
New Rice-based hydrolysate
Intervention Description
A rice-based hydrolysed infant formula with new ingredient
Intervention Type
Other
Intervention Name(s)
Amino Acid-based infant formula
Intervention Description
An amino acid-based infant formula
Primary Outcome Measure Information:
Title
Hypoallergenicity
Description
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).
Time Frame
7 days open challenge
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children <10 yrs of age
Proven IgE-mediated CMA
>2500g at birth
> 37 weeks gestation
Written informed consent provided by parent(s)/guardian
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Meraner
Phone
+39 0473 293 648
Email
Marion.Meraner@drschar-medical.com
Facility Information:
Facility Name
Meyer Children's Hospital
City
Florence
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Completed
Facility Name
Hospital Infantile Regina Margherita.
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof G Monti
First Name & Middle Initial & Last Name & Degree
Dr R Calzedda
Facility Name
Hospital Sant Joan de Déu Barcelona 2020,
City
Barcelona
ZIP/Postal Code
08950 Esplugues de Llobregat,
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof M Alvaro
First Name & Middle Initial & Last Name & Degree
Dr M Sandoval
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
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