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

Nestlé

Status: Enrolling

Conditions: Cow's Milk Protein Allergy

Treatments: Other: Experimental formula; Other: Control formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06633289

2115INF

Details and patient eligibility

About

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).

Enrollment: 67 estimated patients

Sex: All

Ages: 60 days to 3 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups

Experimental formula-Control formula

Other group

Description:

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.

Treatment:

Other: Control formula

Other: Experimental formula

Control formula-Experimental formula

Other group

Description:

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.

Treatment:

Other: Control formula

Other: Experimental formula