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Набор скоро начнётся NCT07342972

Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula

Без фазы С лечением Gastrointestinal Tolerance Gastrointestinal Symptoms Infections Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Goat milk-based infant formula, Cow's milk-based infant formula.
Кому может быть актуально
Состояния в реестре: Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life. Базовые параметры: 14 Days — 90 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Саудовская Аравия
Следующий шаг
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Официальное название

Effect of a Goat-milk Based Infant Formula on Gastrointestinal Symptoms and Tolerability in Healthy Term Infants: a Double-blind Randomized Controlled Trial

Обзор

This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.

Вмешательства

  • Другое Goat milk-based infant formula
    Study product is administered on demand until the age of 6 months.
  • Другое Cow's milk-based infant formula
    Study product is administered on demand until the age of 6 months.

Первичные конечные точки

  • Gastrointestinal symptoms as determined by CoMiSS [Срок оценки: Difference between groups at Day 14 of the intervention]
  • Gastrointestinal tolerance as determined by IGSQ [Срок оценки: Difference between groups at the end of the intervention at 24 weeks]
Вторичные конечные точки (12)
  • Gastrointestinal symptoms throughout the study as determined by CoMiSS [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Gastrointestinal tolerance throughout the study as determined by IGSQ [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of respiratory infections as determined by CARIFS [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Occurrence, duration and severity of ear infections as determined by AOM-SOS V5 [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Quality of life as determined by PedsQL [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Quality of life as determined by WHOQoL-BREF [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Weight [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Height [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Head circumference [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • WHO z-scores [Срок оценки: From enrollment to the end of the intervention at 24 weeks]
  • Fecal parameters [Срок оценки: Baseline, Day 14, Day 28, Week 12 and Week 24]

Критерии участия

Критерии включения

  • Age between 14 days and 90 days.
  • Healthy singleton term infants born between 37 weeks and 42 weeks of gestation.
  • Infants who have received CMF for at least 7 consecutive days.
  • Exclusive formula feeding.
  • Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and <10.
  • Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol

Критерии исключения

  • Exclusively or partially feeding with human milk
  • Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement
  • Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters.
  • Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance.
  • Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication)
  • Sibling already participating in this study
  • Participation in another clinical trial

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Саудовская Аравия · 1 центр
  • King Faissal Specialist Hospital & Research Centre — Riyadh

Идентификаторы

NCT: NCT07342972 · P24-150

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗