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A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 10 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04519827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dr. Schär AG / SPA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy;Food
Additional Details

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).

Arms & Interventions

Arms

Experimental: New Rice-based hydrolysate

The TEST formula is a new Rice-based hydrolysate with new ingredient.

Placebo Comparator: Amino-acid based formula

The PLACEBO is an Amino-acid based formula.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Meyer Children's Hospital, Florence, Italy

Status

Recruiting

Address

Meyer Children's Hospital

Florence, , 50139

Site Contact

Prof F. Mori

francesca.mori@meyer.it

+39 0473 293 648

Hospital Infantile Regina Margherita., Turin, Italy

Status

Not yet recruiting

Address

Hospital Infantile Regina Margherita.

Turin, , 10126

Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Sant Joan de Déu Barcelona 2020,

Barcelona, , 08950 Esplugues de Llobregat,

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