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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04519827
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 24, 2020
Information provided by (Responsible Party):
Dr. Schär AG / SPA

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE August 20, 2020
Last Update Posted Date August 24, 2020
Actual Study Start Date  ICMJE July 28, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Hypoallergenicity [ Time Frame: 7 days open challenge ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Allergy;Food
Intervention  ICMJE
  • Other: New Rice-based hydrolysate
    A rice-based hydrolysed infant formula with new ingredient
  • Other: Amino Acid-based infant formula
    An amino acid-based infant formula
Study Arms  ICMJE
  • Experimental: New Rice-based hydrolysate
    The TEST formula is a new Rice-based hydrolysate with new ingredient.
    Intervention: Other: New Rice-based hydrolysate
  • Placebo Comparator: Amino-acid based formula
    The PLACEBO is an Amino-acid based formula.
    Intervention: Other: Amino Acid-based infant formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marion Meraner +39 0473 293 648
Listed Location Countries  ICMJE Italy,   Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04519827
Other Study ID Numbers  ICMJE CHARM-01-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Schär AG / SPA
Study Sponsor  ICMJE Dr. Schär AG / SPA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr. Schär AG / SPA
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP