Hydrolysed Rice Formula Study

Официальное название

A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy

Обзор

This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.

Вмешательства

• Другое Hydrolysed Rice Protein Formula
  Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
• Другое Cow's Milk Based Extensively Hydrolysed Formula
  Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

Первичные конечные точки

• Growth [Срок оценки: Baseline to three months]

Вторичные конечные точки (11)

• Gastrointestinal Tolerance [Срок оценки: Baseline to three months]
• Stool frequency and consistency [Срок оценки: Baseline to three months]
• Study Product Intake [Срок оценки: Baseline to three months]
• Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD) [Срок оценки: Baseline to three months]
• Patient Reported Atopic Symptoms [Срок оценки: Baseline to three months]
• Cow's Milk Related Symptom Score [Срок оценки: Baseline to three months]
• Food Allergy Quality of Life-Parental Burden (FAQL-PB) [Срок оценки: Baseline to three months]
• Acceptability of the Study Formula [Срок оценки: Baseline to three months]
• Nutrient Intake (Energy, Protein, Micronutrients) [Срок оценки: Baseline to three months]
• Dietetic Goal [Срок оценки: Baseline to three months]
• Overall Safety [Срок оценки: Through study completion, an average of three months]

Критерии участия

Критерии включения

• Male or female
• Aged 0-13 months
• Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA
• Will receive at least 30% of energy requirements from the study formula
• Written informed consent from parent/carer

Критерии исключения

• Severe CMA (including anaphylaxis) and/or requiring an AAF
• Faltering growth (based on NICE guidelines36 - Appendix 1)
• Previous allergy to any study product ingredients (including whey hydrolysate and/or rice)
• Primary lactose intolerance
• Food Protein-Induced Enterocolitis Syndrome (FPIES)
• Exclusively breast fed
• Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes
• Severe hepatic or renal insufficiency
• Premature infants (born <37 weeks) with a corrected age of <4 weeks
• Requirement for any parenteral nutrition
• Participation in other clinical intervention studies within 1 month of recruitment
• Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 2 центра

• Gloucestershire Royal NHS Trust — Gloucester
• Bristol Royal Hospital for Children — Bristol

Идентификаторы

NCT: NCT06288503 · HRF2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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