Influence of Probiotics on Early Gut Microbial Colonization
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: Probiotic drops, Placebo drops.
- Кому может быть актуально
- Состояния в реестре: C-Section. Базовые параметры: 0 Days — 3 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
- Финляндия
- 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
Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
Обзор
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability. An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group. Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.
Вмешательства
- Пищевая добавка Probiotic drops
Probiotic+vitamin D3 drops - Пищевая добавка Placebo drops
Placebo+vitamin D3
Первичные конечные точки
- To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls. [Срок оценки: week 2]
Вторичные конечные точки (11)
- To evaluate the gut microbiome colonization and composition. [Срок оценки: week 2]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months]
- To evaluate the gut microbiome colonization and composition. [Срок оценки: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.]
- To assess quality of life [Срок оценки: Weeks 4 and 8, with optional assessments at 6 and 12 months.]
- To assess quality of life. [Срок оценки: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.]
- To assess quality of life [Срок оценки: Weeks 4 and 8, with optional assessments at 6 and 12 months.]
Критерии участия
Критерии включения
Infant born by planned C-section or vaginal born infant
Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks
Infant Apgar score 7-10, (5 minutes after birth)
Intention to breastfeed the infant
Parents/legal guardians are >18 years
Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples
Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator
Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study
Критерии исключения
>72 hours after birth when collecting the first faecal sample and given the first drops of study product
Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.
Infants with birth of congenital malformations or anomalies
Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)
Infants requiring care in neonatal unit
Disruption of amniotic membranes for >24 hours
Infants consuming probiotics, including in infant formula
Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery
Participation in other clinical studies
Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results
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
- Фундаментальное исследование
Центры проведения
Финляндия · 2 центра
- Helsinki University Hospital — Helsinki
- Tampere University Hospital — Tampere
Идентификаторы
NCT: NCT07608341 · CSUB0198