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.

NCT06633250 | Recruiting

• 1 other identifier: 2204INF
• Study Type: interventional
• Target: 104
• Locations: 3 countries
• Sites: 19

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).

Conditions

Cow Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

• Weight-for-age z-score at 4 months post-enrollment

  Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards.

  From enrollment to 4 months post-enrollment

Secondary Outcomes (17)

• Weight

  Monthly from enrollment to 4 months post-enrollment

• Length

  Monthly from enrollment to 4 months post-enrollment

• Head circumference

  At enrollmentn and 4 months post-enrollment

• Tibia lenght

  At enrollmentn and 4 months post-enrollment

• Femur lenght

  At enrollmentn and 4 months post-enrollment

Study Arms (2)

Test Formula

EXPERIMENTAL

Hydrolyzed rice protein formula

Other: Test Formula

Control Formula

ACTIVE COMPARATOR

Commercially available extensively hydrolyzed cow's milk formula

Other: Control Formula

Interventions

Control Formula OTHER

Commercially available extensively hydrolyzed cow's milk formula

Control Formula

Test Formula OTHER

Hydrolyzed rice protein formula

Test Formula

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
• Infant gestational age ≥ 37 completed weeks
• Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
• Singleton birth
• Infant age ≤ 8 months
• Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
• Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
• 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
• 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
• Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
• 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

You may not qualify if:

• History of intolerance to eHF formula
• Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
• Major gastrointestinal disease / abnormalities (other than CMPA)
• Known or suspected lactose intolerance or malabsorption
• Known or suspected soy allergy
• Glucose-galactose malabsorption
• Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
• Immunodeficiency
• Persistent wheeze or chronic respiratory disease
• Severe uncontrolled eczema
• 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
• Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
• Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment
• 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
• Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (19)

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

RECRUITING

AOUP Ospedale Santa Chiara

Pisa, Italy

COMPLETED

Ospedale Pediatrico Bambino Gesu

Rome, Italy

NOT YET RECRUITING

AO Ordine Mauriziano

Turin, Italy

RECRUITING

Poliklinika Ginekologiczno-Położnicza Arciszewscy

Bialystok, Poland

RECRUITING

Centrum Medyczne Pratia

Bydgoszcz, Poland

RECRUITING

IN-VIVO Bydgoszcz

Bydgoszcz, Poland

RECRUITING

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bydgoszcz, Poland

RECRUITING

Vitamed Galaj i Cichomski

Bydgoszcz, Poland

RECRUITING

BioMedical Centers

Janki, Poland

RECRUITING

Centrum Medyczne Plejady

Krakow, Poland

COMPLETED

Jagiellonian University Medical College

Krakow, Poland

RECRUITING

Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Lodz, Poland

RECRUITING

ETG Lublin

Lublin, Poland

RECRUITING

Korczowski Bartosz Gabinet Lekarski

Rzeszów, Poland

RECRUITING

Alergo-Med Specjalistyczna Przychodnia Lekarska

Tarnów, Poland

RECRUITING

University Hospital of Warsaw

Warsaw, Poland

COMPLETED

Central Study Contacts

Anthony de COZAR

CONTACT

+41762627426; anthony.decozar@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); PL (13); DE (1)