Status:
COMPLETED
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
Allergy;Food
Eligibility:
All Genders
Up to 10 years
Phase:
NA
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...
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)...
Eligibility Criteria
Inclusion
- Children \<10 yrs of age
- Proven IgE-mediated CMA
- \>2500g at birth
- \> 37 weeks gestation
- Written informed consent provided by parent(s)/guardian
Exclusion
- 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
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04519827
Start Date
May 21 2020
End Date
November 29 2023
Last Update
December 8 2023
Active Locations (4)
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1
Meyer Children's Hospital
Florence, Italy, 50139
2
Spett.le Universita degli Studi di Napoli ''Federico II''
Napoli, Italy, 80131
3
Hospital Infantile Regina Margherita.
Turin, Italy, 10126
4
Hospital Sant Joan de Déu Barcelona 2020,
Barcelona, Spain, 08950 Esplugues de Llobregat,