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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.
 
ClinicalTrials.gov Identifier: NCT04519827
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Schär AG / SPA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergy;Food Other: New Rice-based hydrolysate Other: Amino Acid-based infant formula Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519827


Contacts
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Contact: Marion Meraner +39 0473 293 648 Marion.Meraner@drschar-medical.com

Locations
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Italy
Meyer Children's Hospital Recruiting
Florence, Italy, 50139
Contact: Prof F. Mori       francesca.mori@meyer.it   
Contact: Dr G. Liccioli       giulia.liccioli@meyer.it   
Hospital Infantile Regina Margherita. Recruiting
Turin, Italy, 10126
Contact: Prof G Monti         
Contact: Dr R Calzedda         
Spain
Hospital Sant Joan de Déu Barcelona 2020, Recruiting
Barcelona, Spain, 08950 Esplugues de Llobregat,
Contact: Prof M Alvaro         
Contact: Dr M Sandoval         
Sponsors and Collaborators
Dr. Schär AG / SPA
More Information
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Responsible Party: Dr. Schär AG / SPA
ClinicalTrials.gov Identifier: NCT04519827    
Other Study ID Numbers: CHARM-01-2020
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Schär AG / SPA:
Cow's Milk Protein Allergy (CMPA)
Cow's Milk Allergy (CMA)
CHILDREN
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate