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.

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Польша · 13 центров

• 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
• … и ещё 5 центров

Италия · 5 центров

• 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

Германия · 1 центр

• Charité Universitätsmedizin Berlin — Berlin

Публикации

• 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

Идентификаторы

NCT: NCT06633250 · 2204INF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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