Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
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: Vitamin + Zinc + micronutrient mixture, Placebo.
- Кому может быть актуально
- Состояния в реестре: Gastroenteric Tract, Respiratory Tract, Infections, Gastroenteric Infections. Базовые параметры: 12 мес. — 48 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.
Обзор
Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation. Healthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.
Вмешательства
- Пищевая добавка Vitamin + Zinc + micronutrient mixture
a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose. - Пищевая добавка Placebo
Placebo is identical to intervention product
Первичные конечные точки
- Primary outcome [Срок оценки: The dietary supplement and placebo will be administered for three months from the date of enrollment.]
Критерии участия
Критерии включения
- Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
Критерии исключения
- Age less than 12 months and more than 48 months;
- Concomitant presence of chronic diseases
- Congenital heart disease;
- Tuberculosis;
- Functional gastrointestinal disorders;
- Gastrointestinal or urinary surgery of the respiratory tract;
- Autoimmune diseases;
- Immunodeficiencies;
- Chronic inflammatory bowel diseases;
- Celiac disease;
- Cystic fibrosis;
- Metabolic diseases;
- Lactose intolerance;
- Tumors;
- Chronic lung diseases and malformations of the gastrointestinal tract;
- Food allergies;
- Eosinophilic esophagitis;
- Other hypereosinophilic diseases of the gastrointestinal tract;
- Diarrhea at enrollment;
- Severe malnutrition (z score for weight/height less than 3SD);
- Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study;
- Breastfeeding in progress
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
- Профилактика
Центры проведения
Италия · 1 центр
- Pediatria Trambusti — Bari
Публикации
- Siziba LP, Mank M, Stahl B, Kurz D, Gonsalves J, Blijenberg B, Rothenbacher D, Genuneit J. Associations of Human Milk Oligosaccharides With Otitis Media and Lower and Upper Respiratory Tract Infections up to 2 Years: The Ulm SPATZ Health Study. Front Nutr. 2021 Oct 25;8:761129. doi: 10.3389/fnut.2021.761129. eCollection 2021. PMID 34760912
- Etzold S, Bode L. Glycan-dependent viral infection in infants and the role of human milk oligosaccharides. Curr Opin Virol. 2014 Aug;7:101-7. doi: 10.1016/j.coviro.2014.06.005. Epub 2014 Jul 19. PMID 25047751
- Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327. PMID 11387176
Идентификаторы
NCT: NCT07050693 · IMMUNOSICK24