Clinical trial NCT06633250: Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.
Official title: Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cow Milk Protein Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 104
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's 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. Infant gestational age ≥ 37 completed weeks
3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. Singleton birth
5. Infant age ≤ 8 months
6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:

   1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms
   2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present
8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

1. History of intolerance to eHF formula
2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
3. Major gastrointestinal disease / abnormalities (other than CMPA)
4. Known or suspected lactose intolerance or malabsorption
5. Known or suspected soy allergy
6. Glucose-galactose malabsorption
7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
8. Immunodeficiency
9. Persistent wheeze or chronic respiratory disease
10. Severe uncontrolled eczema
11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment
12. Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
13. Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study
15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment

Primary outcomes:
measure: Weight-for-age z-score at 4 months post-enrollment
timeFrame: From enrollment to 4 months post-enrollment
Secondary outcomes:
measure: Weight
timeFrame: Monthly from enrollment to 4 months post-enrollment
measure: Length
timeFrame: Monthly from enrollment to 4 months post-enrollment
measure: Head circumference
timeFrame: At enrollmentn and 4 months post-enrollment
measure: Tibia lenght
timeFrame: At enrollmentn and 4 months post-enrollment
measure: Femur lenght
timeFrame: At enrollmentn and 4 months post-enrollment
measure: Gastrointestinal Symptoms
timeFrame: Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment
measure: Gastrointestinal Symptoms
timeFrame: First 7 days post enrollment
measure: Stool frequency and consistency
timeFrame: At enrollment
measure: Stool frequency and consistency
timeFrame: 2 months and 4 months post-enrollment
measure: Cow's Milk-related Allergy Symptom
timeFrame: Monthly from enrollment to 4 months post-enrollment
measure: Food Allergy Quality of Life
timeFrame: At enrollment and 4 months post-enrollment
measure: Parental self-efficacy in managing food allergy
timeFrame: At enrollment and 4 months post-enrollment
measure: Parent-reported infant health-related quality of life
timeFrame: At enrollment and 4 months post-enrollment
measure: Complementary food intake
timeFrame: At enrollment, 2 months post-enrollment and 4 months post-enrollment
measure: Formula compliance
timeFrame: Monthly from enrollment to 4 months post-enrollment
measure: Formula liking
timeFrame: 4 months post-enrollment
measure: Safety
timeFrame: From enrollment to 4 months post-enrollment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pisa
country: Italy
facility: AOUP Ospedale Santa Chiara
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesu
city: Turin
country: Italy
facility: AO Ordine Mauriziano
city: Bialystok
country: Poland
facility: Poliklinika Ginekologiczno-Położnicza Arciszewscy
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia
city: Bydgoszcz
country: Poland
facility: IN-VIVO Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski
city: Janki
country: Poland
facility: BioMedical Centers
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Lublin
country: Poland
facility: ETG Lublin
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska
city: Warszawa
country: Poland
facility: University Hospital of Warsaw
Study officials:
References: