A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

Not Applicable

Completed

• Conditions: Allergy;Food
• Interventions: Other: Amino Acid-based infant formula; Other: New Rice-based hydrolysate

• Registration Number: NCT04519827
• Lead Sponsor: Dr. Schär AG / SPA

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 Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amino-acid based formula	Amino Acid-based infant formula	The PLACEBO is an Amino-acid based formula.
New Rice-based hydrolysate	New Rice-based hydrolysate	The TEST formula is a new Rice-based hydrolysate with new ingredient.

Primary Outcome Measures

Name	Time	Method
Hypoallergenicity	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).

Trial Locations

Locations (4)

Hospital Sant Joan de Déu Barcelona 2020,; 🇪🇸 Barcelona, Spain

Hospital Infantile Regina Margherita.; 🇮🇹 Turin, Italy

Meyer Children's Hospital; 🇮🇹 Florence, Italy

Spett.le Universita degli Studi di Napoli ''Federico II''; 🇮🇹 Napoli, Italy