Clinical trial NCT06633289: Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
Official title: Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cow's Milk Protein Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 67
Sex: ALL
Minimum age (years): 60
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


Eligibility 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).

Primary outcomes:
measure: Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)
timeFrame: during test day
Secondary outcomes:
measure: Gastrointestinal tolerance of experimental formula during at home consumption period
timeFrame: during 7 days
measure: Safety of experimental formula during the at-home consumption
timeFrame: during 7 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie
city: Firenze
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini
city: Milan
country: Italy
facility: Ospedale dei Bambini V. Buzzi Via Castelvetro, 32
city: Naples
country: Italy
facility: Universiy of Naples Federico II
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma, Italy
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University in Torun
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Warsaw
country: Poland
facility: BioMedical Centers sp. z o.o.
city: Warsaw
country: Poland
facility: Pediatrics Department at the Medical University of Warsaw
Study officials:
References: