RecruitingNot ApplicableNCT06633250

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.

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


Sponsor

Société des Produits Nestlé (SPN)

Enrollment

104 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 8 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control Formula and Test Formula for people with cow milk protein allergy. The study is currently recruiting participants at 19 locations. People eligible for this study include up to age 8 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTest Formula

Hydrolyzed rice protein formula

OTHERControl 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

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NCT06633250