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Идёт набор NCT05783141

Prebiotic Effects in Healthy Toddlers

Без фазы С лечением Child Development Diet, Healthy

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: New prebiotic follow-on formula, randomly assigned to healthy toddlers, Standard follow-on formula, randomly assigned to healthy toddlers.
Кому может быть актуально
Состояния в реестре: Child Development, Diet, Healthy. Базовые параметры: 10 мес. — 36 мес. · 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
Бельгия
Следующий шаг
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Официальное название

Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers

Обзор

The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.

Подробное описание

The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.

Вмешательства

  • Пищевая добавка New prebiotic follow-on formula, randomly assigned to healthy toddlers
    Standard follow-on formula administered orally
  • Пищевая добавка Standard follow-on formula, randomly assigned to healthy toddlers
    Standard follow-on formula administered orally

Первичные конечные точки

  • Fever [Срок оценки: Data collected continuously from enrollment until end of intervention (up to 90 days).]
  • Absenteeism [Срок оценки: Data collected continuously from enrollment until end of intervention (up to 90 days).]
Вторичные конечные точки (4)
  • Beneficial colonization [Срок оценки: Stool sample collected at baseline and after 90 days intervention period]
  • Stool consistency [Срок оценки: Data collected continuously from enrollment until end of intervention (up to 90 days).]
  • Stool frequency [Срок оценки: Data collected continuously from enrollment until end of intervention (up to 90 days).]
  • Caretaker´s absenteeism from work [Срок оценки: Data collected continuously from enrollment until end of intervention (up to 90 days).]

Критерии участия

Критерии включения

  • Child is healthy at the time of pre-examination
  • Child is aged between 10-36 months and attends a day care center for the duration of the intervention
  • Child attends a daycare center at the time of pre examination for at least 50%.
  • Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
  • Weight for height z-score >-2 and <2 SD based on Flemish growth charts
  • Child and legal guardian are able and willing to follow the study instructions
  • Child is suitable for participation in the study according to the investigator/ study personnel
  • Informed written consent given by parent / legal guardian

Критерии исключения

  • No legal guardian's command of any local language
  • Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
  • Child is suffering from congenital or acquired immunodeficiency
  • Food allergies or intolerances
  • Child is currently breast-fed more than once daily
  • Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
  • Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
  • Child is suffering from an infection at the time of pre examination or previous 7 days
  • Child is currently involved or will be involved in another clinical or food study
  • Child is not suitable for participation in the study according to the study personnel´s opinion

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
Профилактика

Центры проведения

Бельгия · 1 центр
  • Universitair Ziekenhuis Brussel — Brussels

Идентификаторы

NCT: NCT05783141 · 22006n-mpz

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗