Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Microbial composition profiles in fecal sample
研究概览
简要总结
This single-center randomized controlled trial evaluates whether donor-derived fecal microbiota transplantation (FMT) administered within 6 hours after birth can improve gut microbiota development and reduce the risk of immune-mediated and metabolic diseases in infants born by elective cesarean delivery. Newborns are randomized 1:1 to receive either donor-derived FMT or standard postnatal care. Participants are followed through 36 months of age with stool samples, questionnaires, growth assessments, and health data collection, with registry-based follow-up continuing until 10 years of age.
详细描述
This is a single-center, randomized, controlled trial conducted at Oulu University Hospital, Finland. The study aims to investigate whether administration of donor-derived microbiota transplantation shortly after birth can modify gut microbiota development and reduce the risk of immune-mediated and metabolic diseases among children born by elective cesarean delivery.
Pregnant women aged 18 to 49 years scheduled for elective cesarean delivery at term are contacted by a study nurse approximately one week before the planned delivery. Interested families receive detailed information about the study, and written informed consent is obtained before delivery.
Eligible newborns are randomized in a 1:1 ratio using block randomization to either the intervention group or the control group. Infants in the intervention group receive microbiota transplantation from a healthy female donor selected from the study microbiota bank within 6 hours after birth. Infants in the control group receive standard postnatal care without microbiota transplantation.
Maternal exclusion criteria include age below 18 or above 49 years, multiple pregnancy, regular use of immunosuppressive biological medication, diagnosed immunodeficiency in the mother or a first-degree relative of the unborn child, and known or suspected major congenital structural anomalies or immunodeficiency in the fetus. Infant exclusion criteria include preterm birth (<37 completed weeks of gestation), birth weight <2500 g, admission to a neonatal intensive care unit, requirement for respiratory support, or need for systemic antibiotic treatment before administration of the intervention.
Participants are followed longitudinally from birth through early childhood. Follow-up assessments include stool sample collection, questionnaires, growth measurements, and health data obtained from medical records and national health registries. Study visits and data collection are performed at predefined time points from birth to 36 months of age. Long-term follow-up using registry-based data will continue until 10 years of age, subject to parental consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group.
入排标准
- 年龄范围
- 0 Hours 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18 to 49 years Scheduled for elective cesarean delivery at term (≥37 completed weeks of gestation) Willing and able to provide written informed consent Infant eligible for study participation following birth
排除标准
- •Age <18 years or >49 years Multiple pregnancy Regular use of immunosuppressive biological medication Diagnosed immunodeficiency in the mother Diagnosed immunodeficiency in a first-degree relative of the unborn child Known or suspected major congenital structural anomaly in the fetus Known or suspected fetal immunodeficiency Previous participation in the SISU-FMT study
- •Exclusion Criteria (Infant):
- •Preterm birth (<37 completed weeks of gestation) Birth weight <2500 g Admission to a neonatal intensive care unit prior to the intervention Requirement for respiratory support prior to the intervention Requirement for systemic antibiotic treatment prior to the intervention
研究组 & 干预措施
Controls
230 mothers and infants are recruited in no intervention group.
Fecal microbiota transplant from biobank
The newborns receive fecal microbiota transplant from their own mother (230 newborns).
干预措施: Donor-derived fecal microbiota transplantation (Dietary Supplement)
结局指标
主要结局
Microbial composition profiles in fecal sample
时间窗: Until 12 months of age
The difference in microbial composition profiles in fecal sample between the infants in different study groups, specifically diversity and relative abundances of different bacteria phyla and species.
Height z-score
时间窗: 3 years of age
The difference in growth in height between the infants in different study groups
Height in centimeters
时间窗: 3 years of age
The difference in growth in height between the infants in different study groups
Weight in kilograms
时间窗: 3 years of age
The difference in growth in weight in infants the infants in different study groups
Weight-for-length (%)
时间窗: 3 years of age
The difference in growth in weight in infants the infants in different study groups
Composite incidence of immune-mediated and metabolic disorders
时间窗: Birth to 10 years of age
Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.
次要结局
- The source of colonization by exclusively shared genes (ESGs)(3 month of age)
- Microbial composition profiles in fecal sample(Until 12 months of age)
- Height in centimeters(10 years of age)
- Weight-for-length (%)(10 years of age)
- Weight in kilograms(10 years of age)
- Height z-score(10 years of age)
- Incidence of allergic diseases(Birth to 10 years of age)
- Incidence of obstructive respiratory disease(Birth to 10 years of age)
- Incidence of autoimmune diseases(Birth to 10 years of age)
研究者
Marika Paalanne
MD, PhD, Associate Professor
Oulu University Hospital