Cow's Milk Protein Allergy
Conditions
Brief summary
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).
Interventions
OTHERExperimental formula
New hydrolyzed rice protein-based formula
OTHERControl formula
Commercially available amino acid-based formula.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Days to 3 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula) | during test day | by measuring the proportion of participants who passed the food challenge test, meaning who consumed all doses and exhibited no allergic reactions to any of the doses of the experimental formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance of experimental formula during at home consumption period | during 7 days | by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary |
| Safety of experimental formula during the at-home consumption | during 7 days | By assessing the frequency and severity of adverse events reported by parents during the home usage phase |
Countries
Germany, Italy, Poland
Contacts
Primary ContactJulia Mauger
Outcome results
None listed