NCT07608341尚未招募不适用
Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioGaia AB
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •>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
研究者
研究点 (2)
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