Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

Study Purpose

The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).

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	60 Days - 3 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

1. Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable) 2. Child gestational age ≥ 37 completed weeks. 3. Child aged ≥ 60 days and less than 36 months at enrollment. 4. Documented IgE-mediated CMPA no more than 6 months prior to enrollment. 5. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study. 6. Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.

Exclusion criteria:

1. Child is exclusively breastfed. 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies. 3. Congenital heart disease or treatment by B-blockers. 4. Major gastrointestinal disease / abnormalities (other than CMPA) 5. Known or suspected soy allergy. 6. Glucose-galactose malabsorption. 7. Immunodeficiency. 8. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment. 9. Persistent wheeze or chronic respiratory disease. 10. Severe uncontrolled eczema or urticaria. 11. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome), or allergy to any ingredient in the formulas. 12. Child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the child inappropriate for entry into the study. 13. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment. 14. Child's parents have not reached legal age of majority (18 years).

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.	NCT06633289
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.	Société des Produits Nestlé (SPN)
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	Not yet recruiting
Countries	Germany, Italy, Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow's Milk Protein Allergy

Arms & Interventions

Arms

Other: Experimental formula-Control formula

Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.

Other: Control formula-Experimental formula

Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days.

Interventions

Other: - Experimental formula

New hydrolyzed rice protein-based formula

Other: - Control formula

Commercially available amino acid-based formula.

Contact a Trial Team

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