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. (RIGHT-GO)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cow Milk Protein Allergy
• Intervention / Treatment: Other: Test Formula; Other: Control Formula

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony de COZAR; Phone Number: +41762627426; Email: anthony.decozar@rd.nestle.com

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Brigit Kalb, Dr; Email: birgit.kalb@charite.de
• Italy
  • Naples, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Federico II
    • Contact: Roberto Berni Canani, Pr; Email: berni@unina.it
  • Parma, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria di Parma
    • Contact: Susanna Esposito, Pr
  • Pisa, Italy
    • Completed
    • AOUP Ospedale Santa Chiara
  • Rome, Italy
    • Not yet recruiting
    • Ospedale Pediatrico Bambino Gesu
    • Contact: Vincenzo Fierro, Dr
  • Turin, Italy
    • Recruiting
    • AO Ordine Mauriziano
    • Contact: Emilia Parodi, Dr
• Poland
  • Bialystok, Poland
    • Recruiting
    • Poliklinika Ginekologiczno-Położnicza Arciszewscy
    • Contact: Malgorzata Arciszewska, Dr
  • Bydgoszcz, Poland
    • Recruiting
    • IN-VIVO Bydgoszcz
    • Contact: Piotr Korbal, Dr
  • Bydgoszcz, Poland
    • Recruiting
    • Centrum Medyczne Pratia
    • Contact: Oleg Warszalewski, Dr
  • Bydgoszcz, Poland
    • Recruiting
    • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
    • Contact: Anna Płoszczuk, Dr
  • Bydgoszcz, Poland
    • Recruiting
    • Vitamed Galaj i Cichomski
    • Contact: Andrzej Galaj, Dr
  • Janki, Poland
    • Recruiting
    • BioMedical Centers
    • Contact: Karolina Kolakowska, Dr
  • Krakow, Poland
    • Completed
    • Centrum Medyczne Plejady
  • Krakow, Poland
    • Recruiting
    • Jagiellonian University Medical College
    • Contact: Urszula Jedynak-Wasowicz, Dr
  • Lodz, Poland
    • Recruiting
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
    • Contact: Agnieszka Brzozowska, Dr
  • Lublin, Poland
    • Recruiting
    • ETG Lublin
    • Contact: Zofia Bartnik, Dr
  • Rzeszów, Poland
    • Recruiting
    • Korczowski Bartosz Gabinet Lekarski
    • Contact: Bartosz Korczowski, Pr
  • Tarnów, Poland
    • Recruiting
    • ALERGO-MED Specjalistyczna Przychodnia Lekarska
    • Contact: Bernadetta Majorek-Olechowska
  • Warsaw, Poland
    • Completed
    • University Hospital of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Formula; Hydrolyzed rice protein formula	Other: Test Formula; Hydrolyzed rice protein formula
Active Comparator: Control Formula; Commercially available extensively hydrolyzed cow's milk formula	Other: Control Formula; Commercially available extensively hydrolyzed cow's milk formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight (g and z-scores)	Monthly from enrollment to 4 months post-enrollment
Length	Length (cm and z-scores)	Monthly from enrollment to 4 months post-enrollment
Head circumference	Head circumference (cm and z-scores)	At enrollmentn and 4 months post-enrollment
Tibia lenght	Tibia (cm)	At enrollmentn and 4 months post-enrollment
Femur lenght	Femur (cm)	At enrollmentn and 4 months post-enrollment
Gastrointestinal Symptoms	The Infant Gastrointestinal Symptom Questionnaire (IGSQ) will be used to assess GI tolerance. The IGSQ is a validated instrument that includes 13 questions in 5 domains (stooling, spitting-up/vomiting, crying, fussiness, and flatulence) and total scores range from 13 (best) to 65 (worst) for overall GI symptom burden.	Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment
Gastrointestinal Symptoms	A daily GI tolerance questionnaire will be used.	First 7 days post enrollment
Stool frequency and consistency	A retrospective 1-day stool record including the Brussels Infant and Toddler Stool Scale will be used.	At enrollment
Stool frequency and consistency	A 3-day stool diary including the Brussels Infant and Toddler Stool Scale will be used.	2 months and 4 months post-enrollment
Cow's Milk-related Allergy Symptom	The Cow's Milk-related Symptom Score (CoMiSS) will be used to assess symptoms related to CMPA. The CoMiSS questionnaire contains 6 items and generates a score based on gastrointestinal, dermatological, respiratory, and general symptoms (total score range 0-33), which may be associated with CMPA .	Monthly from enrollment to 4 months post-enrollment
Food Allergy Quality of Life	The Food Allergy Quality of Life Questionnaire (FAQLQ-PF) will be used. It is a validated instrument with 30 items in 3 domains (emotional impact, food-related anxiety, dietary and social restrictions).	At enrollment and 4 months post-enrollment
Parental self-efficacy in managing food allergy	Parental self-efficacy in managing their child's food allergy will be assessed using the Food Allergy Self-Efficacy Scale for Parents (FASE-P). The FASE-P is a validated instrument with 21 items.	At enrollment and 4 months post-enrollment
Parent-reported infant health-related quality of life	Parent-reported infant health-related quality of life will be assessed using the Infant and Toddler Quality of Life Questionnaire - Short Form (ITQOL-SF47). The ITQOL-SF47 is a validated instrument with 47 items.	At enrollment and 4 months post-enrollment
Complementary food intake	Total energy and macronutrient intake calculated from food recalls / diaries.	At enrollment, 2 months post-enrollment and 4 months post-enrollment
Formula compliance	A questionnaire will be used to assess formula compliance.	Monthly from enrollment to 4 months post-enrollment
Formula liking	A questionnaire will be used to assess formula liking.	4 months post-enrollment
Safety - Occurence of AE	Adverse Events will be collected.	From enrollment to 4 months post-enrollment

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2204INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No