Lactobacillus Reuteri Feasibility Study on Probiotic Lozenges, Probiotic Chewing Gum and Probiotic Capsules and Perinatal Microbiome Seeding During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Presence of Lactobacillus reuteri in different compartments in the mother and the Child.
研究概览
简要总结
Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to pregnant women can be found in different maternal compartments and in the first stool and oral swab collected immediately after birth of a newborn delivered by cesarean delivery. Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the level of inflammation in different compartments of the mother and the infant.
详细描述
The purpose of this project is to better understand the following issues:
- How does bacteria transmit from the mother to the fetus and placenta during pregnancy and to the infant during the first 2-6 weeks after birth?
- Does colonization of the pregnant mother and fetus/Child occur? How and when?
- Can orally given probiotic bacteria be found in the newborn 2-6 weeks after birth, and if so where?
- How is bacteria transported from the mother's intestinal lumen to the Child/fetus gut?
- What impact has these bacteria on the level of inflammation in maternal and fetal compartments, especially that normally seen in the intestine of all newborns?
- What impact has these bacteria in the bowel on a normal intestinal flora establishment?
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Single or multiple gestation
- •Maternal age > or = 18 y
排除标准
- •Known structural or chromosomal fetal malformation or abnormality
- •Occlusive placenta previa, placenta previa in the anterior wall of the uterus, suspicion of accreta/increta/percreta infiltration
- •Unable to understand information about the study due to language or severe mental disease
- •Known Hepatitis B, C, HIV
- •Known immunosuppressive illness if they are under treatment
- •Treatment with cytokine, methotrexate or immunosuppresses cytotoxics in the last 6 months before the study.
- •Gastro-intestinal surgery including gastric bypass or huge intestinal resection.
- •Anaphylactic shock
- •Uterus malformation that occludes cervical Canal or uterus segment.
研究组 & 干预措施
probiotic lozenge
Two probiotic lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
干预措施: Probiotic lozenges (Drug)
Probiotic capsule
Two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
干预措施: Probiotic capsules (Drug)
Probiotic chewing gum
The probiotic chewing gum should be chewed on for about 10 minutes. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
干预措施: Probiotic chewing gum (Drug)
Placebo lozenge
Two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
干预措施: Placebo lozenges (Drug)
Placebo capsule
Two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Presence of Lactobacillus reuteri in different compartments in the mother and the Child.
时间窗: Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.
Both cultivation techniques for the specific bacteria and metagenomic techniques will be used to be able to study both cultivable and non-cultivable bacteria.
次要结局
- Levels of IL-6, IL-10, IL-1beta, MCP-1, IL-17, TNF-alfa after probiotic treatment and after placebo in different maternal and neonatal compartments.(Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.)
- Levels of Toll-like receptor stimulated with Lactobacillus plantarum, Pseudomonas aeruginosa and LPS after probiotic treatment and after placebo in different maternal and neonatal compartments.(Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.)
研究者
Bo Jacobsson
Clinical professor
Sahlgrenska University Hospital, Sweden