Infant Microbiota Restoration With Maternal Microbes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Microbiota composition, relative and absolute abundances
研究概览
简要总结
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:
Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.
Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
详细描述
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy mother and healthy pregnancy
- •Singleton pregnancy,
- •Mothers who speak Finnish or Swedish
- •Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- •Infants who are expected to be healthy and who will not require BCG vaccination.
排除标准
- •Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- •Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- •Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- •Premature infants born before the pregnancy week 37
- •Infants, who are born by urgent cesarean section or emergency cesarean section
- •Infants, who receive antibiotics during the first week of life
- •Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.
- •Infants, who receive BCG-vaccine
结局指标
主要结局
Microbiota composition, relative and absolute abundances
时间窗: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.
Similarity of the overall gut, mouth, and skin microbiota composition
Fecal metabolite profiles
时间窗: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks
Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group.
次要结局
未报告次要终点
研究者
Katri Korpela
Associate Professor
University of Helsinki