Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety; Incidence of Treatment- Adverse Events eg. infections and increased need for respiratory support
研究概览
简要总结
The goal of this clinical trial is to study if a oral maternal fecal transplant given to a premature infant born by cesarean section (CS) is safe. The investigators will also compare the gut microbiome of the infants to those born by CS and not received the transplant and to premature infants born vaginally.
详细描述
At the Department of Obstetrics at Helsinki University Hospital the investigators will recruit 36 pregnant women (allowing for screening positivity) between 29 and 34 weeks of pregnancy with for example pre-eclampsia or cervix insufficiency, but are otherwise healthy. The mothers fecal sample is carefully screened in case of contagious diseases. The investigators are aiming to recruit 18 mothers with negative screening samples.
The infants are born at gestational week 30-35 either vaginally or by CS. Group A (study group): 10 preterm infants born by CS. These infants will receive a maternal FMT, which will be administered when they tolerate milk at least 40 mL/day. Group B (comparison group): 8 preterm infants from the screening negative mothers and 4 infants from the mothers who have a positive finding in the screening samples (in case the positive finding is a mild pathogen e.g. Dientamoeba fragilis or Blastocystis hominis) born by CS. In case of antibiotic treatment of the infant, the transplant is given not earlier than 48 hours after the last dose, but not later than 7 days of age. Group C: Comparison group of preterm infants born vaginally 30-35 weeks of gestation. For the comparison group, only fecal samples are obtained as in the other groups.
For group A, blood samples are taken on the day of transplant and 1 and 3 days after. The samples are the same as in SECFLOR main trial: research samples and assessment of routine inflammatory markers (such as CBC and CRP).
From the comparison group (B) CRP and blood count samples are taken as ordered by the treating physician. To assess immunological markers a sample of 1 mL is taken at the age of 5-7 days concomitantly with blood samples ordered by the treating physician. No additional samples are taken from the vaginal delivery group.
From all groups: Meconium sample is collected, and then a stool sample on the day of the transplant, and two days after (from the intervention group only) and starting from 1 weeks of age weekly until the age of 4 weeks or until discharged from the intensive unit. After discharge the parents will collect a stool sample of the child at the age of 3, 6, 9 and 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with preeclampsia or other risk factors of preterm labor (eg cervix insufficiency or placenta previa) between 29+0 - 34+0 weeks of pregnancy.
- •Either parent fluent in Finnish.
排除标准
- •Women with other significant medical conditions including acute infection, IBD, celiac disease.
- •Travelling outside the EU and use of antibiotics during the last 3 months.
- •Gestational diabetes with insulin medication.
- •Pregnant with multiples.
结局指标
主要结局
Safety; Incidence of Treatment- Adverse Events eg. infections and increased need for respiratory support
时间窗: 3 months
The primary outcome of the study is safety of the transplantation process. The patients are followed with measurements of markers of inflammation (C-reactive protein (CRP) and blood leucocytes) on the day of transplant and three consecutive days. Clinical symptoms of infection are monitored (such as apnea, tachycardia, fever) as well as symptoms of the gastrointestinal tract (vomiting, diarrhea, feeding intolerance). Any suspected adverse events (such as infections, increased need for respiratory support) are recorded.
次要结局
- The secondary outcome is the difference in heterogeneity of the intestinal microbiome between infants receiving transplant and the control subjects at 3 and 6 months of age.(6 months)
研究者
Otto Helve
Docent
Helsinki University Central Hospital