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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04519827
Other study ID # CHARM-01-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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