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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.
Sponsor: Société des Produits Nestlé (SPN)
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).
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
Key Details
Gender
All
Age Range
Any - 8 Months
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2024-10-25
Completion Date
2026-08
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
Test Formula
Hydrolyzed rice protein formula
Control Formula
Commercially available extensively hydrolyzed cow's milk formula
Locations (19)
Charité Universitätsmedizin Berlin
Berlin, Germany
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
AOUP Ospedale Santa Chiara
Pisa, Italy
Ospedale Pediatrico Bambino Gesu
Rome, Italy
AO Ordine Mauriziano
Turin, Italy
Poliklinika Ginekologiczno-Położnicza Arciszewscy
Bialystok, Poland
Centrum Medyczne Pratia
Bydgoszcz, Poland
IN-VIVO Bydgoszcz
Bydgoszcz, Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bydgoszcz, Poland
Vitamed Galaj i Cichomski
Bydgoszcz, Poland
BioMedical Centers
Janki, Poland
Centrum Medyczne Plejady
Krakow, Poland
Jagiellonian University Medical College
Krakow, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, Poland
ETG Lublin
Lublin, Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska
Tarnów, Poland
University Hospital of Warsaw
Warsaw, Poland