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.

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

Overview

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).

Interventions

• Other Test Formula
  Hydrolyzed rice protein formula
• Other Control Formula
  Commercially available extensively hydrolyzed cow's milk formula

Primary outcome measures

• Weight-for-age z-score at 4 months post-enrollment [Time frame: From enrollment to 4 months post-enrollment]

Secondary outcome measures (12)

• Weight [Time frame: Monthly from enrollment to 4 months post-enrollment]
• Length [Time frame: Monthly from enrollment to 4 months post-enrollment]
• Head circumference [Time frame: At enrollmentn and 4 months post-enrollment]
• Tibia lenght [Time frame: At enrollmentn and 4 months post-enrollment]
• Femur lenght [Time frame: At enrollmentn and 4 months post-enrollment]
• Gastrointestinal Symptoms [Time frame: Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment]
• Gastrointestinal Symptoms [Time frame: First 7 days post enrollment]
• Stool frequency and consistency [Time frame: At enrollment]
• Stool frequency and consistency [Time frame: 2 months and 4 months post-enrollment]
• Cow's Milk-related Allergy Symptom [Time frame: Monthly from enrollment to 4 months post-enrollment]
• Food Allergy Quality of Life [Time frame: At enrollment and 4 months post-enrollment]
• Parental self-efficacy in managing food allergy [Time frame: At enrollment and 4 months post-enrollment]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Poland · 13 centers

• Poliklinika Ginekologiczno-Położnicza Arciszewscy — Bialystok
• Centrum Medyczne Pratia — Bydgoszcz
• IN-VIVO Bydgoszcz — Bydgoszcz
• Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny — Bydgoszcz
• Vitamed Galaj i Cichomski — Bydgoszcz
• BioMedical Centers — Janki
• Centrum Medyczne Plejady — Krakow
• Jagiellonian University Medical College — Krakow
• … and 5 more centers

Italy · 5 centers

• Azienda Ospedaliera Universitaria Federico II — Naples
• Azienda Ospedaliero Universitaria di Parma — Parma
• AOUP Ospedale Santa Chiara — Pisa
• Ospedale Pediatrico Bambino Gesu — Rome
• AO Ordine Mauriziano — Turin

Germany · 1 center

• Charité Universitätsmedizin Berlin — Berlin

Publications

• Zemrani B, Hays NP, Darwish N, Beyer K, Berni Canani R, Szajewska H; RIGHT-GO Consortium. Growth and safety of infants with cow's milk allergy receiving a new hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose: protocol for a randomized clinical trial. The RIGHT-GO study. Front Nutr. 2026 Apr 24;13:1784490. doi: 10.3389/fnut.2026.1784490. eCollection 2026. PMID 42111853

Identifiers

NCT: NCT06633250 · 2204INF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗