Actively Recruiting
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.
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-26
104
Participants Needed
19
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from at least one parent or legal representative
- Infant gestational age of 37 or more completed weeks
- Infant birth weight between 2.5 kg and 4.5 kg
- Singleton birth
- Infant age 8 months or younger
- Mother has decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- Suspected CMPA with at least 2 symptoms such as inconsolable crying, regurgitation, liquid stools, constipation, skin atopic lesions, temporary urticaria/angioedema, vomiting, bloody stool streaks, or respiratory symptoms; or at least 1 symptom if diagnosis is based on positive IgE blood test, skin prick test, or food challenge
- Infant on strict cow's milk elimination diet and will continue this diet during the study
- Parent/legal representative is of legal age, has parental authority, understands consent and study documents, and agrees to study requirements
You will not qualify if you...
- History of intolerance to extensively hydrolyzed formula
- Any chronic medical diseases except atopic eczema, chromosomal or major congenital anomalies
- Major gastrointestinal diseases or abnormalities other than CMPA
- Known or suspected lactose intolerance or malabsorption
- Known or suspected soy allergy
- Glucose-galactose malabsorption
- Rice protein allergy or intolerance, including rice protein-induced enterocolitis syndrome
- Immunodeficiency
- Persistent wheeze or chronic respiratory disease
- Severe uncontrolled eczema
- History of severe anaphylactic reaction requiring 2 or more doses of epinephrine to cow's milk or breast milk
- Weight-for-age value below -2 or above 2 standard deviations from WHO median at enrollment
- Height-for-age below -2 or above 2 standard deviations from WHO median at enrollment
- Parent has medical or psychiatric condition making infant inappropriate for study
- Participation in another interventional clinical study within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
Charité Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
2
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Actively Recruiting
3
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Actively Recruiting
4
AOUP Ospedale Santa Chiara
Pisa, Italy
Completed
5
Ospedale Pediatrico Bambino Gesu
Rome, Italy
Not Yet Recruiting
6
AO Ordine Mauriziano
Turin, Italy
Actively Recruiting
7
Poliklinika Ginekologiczno-Położnicza Arciszewscy
Bialystok, Poland
Actively Recruiting
8
Centrum Medyczne Pratia
Bydgoszcz, Poland
Actively Recruiting
9
IN-VIVO Bydgoszcz
Bydgoszcz, Poland
Actively Recruiting
10
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bydgoszcz, Poland
Actively Recruiting
11
Vitamed Galaj i Cichomski
Bydgoszcz, Poland
Actively Recruiting
12
BioMedical Centers
Janki, Poland
Actively Recruiting
13
Centrum Medyczne Plejady
Krakow, Poland
Completed
14
Jagiellonian University Medical College
Krakow, Poland
Actively Recruiting
15
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, Poland
Actively Recruiting
16
ETG Lublin
Lublin, Poland
Actively Recruiting
17
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
Actively Recruiting
18
Alergo-Med Specjalistyczna Przychodnia Lekarska
Tarnów, Poland
Actively Recruiting
19
University Hospital of Warsaw
Warsaw, Poland
Completed
Research Team
A
Anthony de COZAR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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