Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Verum, Active comparator.
- Кому может быть актуально
- Состояния в реестре: Infant Colic, Gut Microbiota. Базовые параметры: 0 мес. — 9 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
Randomized Double-blind Monocentric Clinical Trial on the Effect of a Dietary Supplement vs Low-dosage Product on Reduction of Infant Gastrointestinal Discomfort and Colics
Обзор
The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species. The main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.
Подробное описание
Infant colic, characterized by excessive crying/fussing for no apparent cause, is common and distressing to families.
The exact causes of infant colic are heterogeneous and not fully understood in detail, but some likely hypotheses point on factors such as gut dysmotility and food intolerance. Growing evidence suggests that the gut microbiota could be also involved in colics: a higher amount of Coliforms and a lower amount of Lactobacilli have been found in colicky infants compared to non-colicky subjects, and probiotic supplementation with Lactobacillus reuteri has been shown to be effective in treating the condition in some clinical trials of breastfed infants.
In the present study, the investigator performs a randomized controlled clinical trial aimed to verify whether a food supplement is effective in treating infantile colic of infants and colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species.
The product is a food supplement based on freeze-dried probiotics (Lactobacillus reuteri DSM 25175 and Lactobacillus acidophilus DSM 24936) and chamomile oleolite to promote the balance of the intestinal bacterial flora, on gastrointestinal discomfort in children aging 0-9 months.
Treatment consists of taking the product or the low-dosage product 7 drops x 2/die for a 30-days. A follow-up was made after 30 days wash out.
Infant colics are diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability
* preverbal patient pain scale) and G4 Infant Colic Rome IV criteria, while relative abundance of the gut microbiota probiotic treatment species (L. reuteri and L. acidophilus) will be evaluated using quantitative PCR (Polymerase Chain Reaction), in order to identify the colonization ability of the study treatment (Fecal sample).
Вмешательства
- Пищевая добавка Verum
1st cycle - 30 days continuous use Cycle 2 - 30-day washout - Пищевая добавка Active comparator
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Первичные конечные точки
- Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying [Срок оценки: T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days)]
Вторичные конечные точки (1)
- Evaluation of relative abundance of the gut microbiota probiotic treatment species [Срок оценки: Faecal samples will be collected from each subject before starting supplementation, at the end of the study period T3 (30 days) and at T4 (after 30 days wash out) and will be analyzed.]
Критерии участия
Критерии включения
- Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria
Критерии исключения
- infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician
- infants participating in other clinical studies
- age ≥ 9 months
- neurological diseases
- suspected or confirmed food allergy to the ingredients of the products under study
- gastroesophageal reflux disease
- use of antibiotics 1-2 weeks before enrolment
- use of gastric acidity inhibitors at any time before enrolment
- fever and/or infectious diseases at any time before enrolment
- current systemic infections
- history of congenital infections
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Gioacchino Calapai — Messina
Идентификаторы
NCT: NCT07017244 · ENTEROBABY