Influence of Probiotics on Early Gut Microbial Colonization (STORKIE)
Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sofia Nordh, PhD
- 电话号码：+46 (0)8 555 293 00
- 邮箱：son@biogaianewsciences.com
学习地点
-
-
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Helsinki、芬兰
- Helsinki University Hospital
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接触：
- Samuli Rautava, MD
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Tampere、芬兰
- Tampere University Hospital
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接触：
- Sauli Palmu, MD
-
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
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
Exclusion Criteria:
>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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Probiotic+ Vitamin D3
C-section, active group
|
Probiotic+vitamin D3 drops
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|
安慰剂比较：Placebo+ Vitamin D3
C-section, placebo group
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Placebo+vitamin D3
|
|
安慰剂比较：Placebo+ Vitamin D3 open label group
Vaginal, placebo group
|
Placebo+vitamin D3
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
大体时间：week 2
|
To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
|
week 2
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To evaluate the gut microbiome colonization and composition.
大体时间：week 2
|
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
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week 2
|
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To evaluate the gut microbiome colonization and composition.
大体时间：Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate the faecal relative abundance and composition of Actinobacteria over time
|
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.
大体时间：Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate the faecal relative abundance of Bifidobacterium over time
|
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.
大体时间：Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate faecal relative abundance and composition of Proteobacteria over time
|
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.
大体时间：Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate faecal relative abundance and composition of Enterobacteriaceae over time
|
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.
大体时间：Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
To evaluate faecal relative abundance and composition of Bacillota over time
|
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.
大体时间：Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
|
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.
大体时间：Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
|
To assess quality of life
大体时间：Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
|
To assess quality of life.
大体时间：Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
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To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
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Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
|
|
To assess quality of life
大体时间：Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
合作者和调查者
赞助
合作者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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