The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Alpha 1 antitrypsin
研究概览
简要总结
Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality.
Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women ,gestation age 32-34 weeks, normal pregnancy, plan to deliver spontaneously, no antibiotic
- •tend to give exclusive breastfeeding
- •want to join the research
- •well doing baby
排除标准
- •pregnant women with pre-eclampsia,bleeding,infection,premature rupture of the membrane or other chronic disease
- •plan to deliver by caesarean section
结局指标
主要结局
Alpha 1 antitrypsin
时间窗: 3 months
Gastrointestinal microbiota examination by DNA extraction and real time PCR
时间窗: 3 months
Examination of IL-8 in breast milk
时间窗: 3 months
Examination of urine IFABP
时间窗: 3 months
Calprotectin examination in stool of infants aged 3 months
时间窗: 3 months
次要结局
未报告次要终点
研究者
Naomi Esthernita
MD
Indonesia University