The Composition of the Intesinal Microbiome in Women With Complication-free Pregnancy and Women With Recurrent Spontaneous Abortions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intestinal microbiome
研究概览
简要总结
Up to 50% of all women suffer of a spontaneous abortion. Having two/three or more spontaneous abortions is one of the main reasons of unwanted childlessness. It is well known that the intestinal microbiome has many important roles in a healthy organism. Simultaneously, a dysbiosis can lead to diseases like, for example, chronic inflammatory bowel diseases, autoimmune diseases or diabetes. Several studies showed that there is a connection between a vaginal dysbiosis and premature birth or late abortion. It is still unclear what effects the composition of the intestinal microbiome before pregnancy has on the course of pregnancy.
This study will be investigate if there is a connection between the composition of the intestinal microbiome and the occurence of recurrent spontaneous abortions.
详细描述
This study wants to investigate if there is a connection between the composition of the intestinal microbiome before pregnancy and the occurence of recurrent spontaneous abortions. Herefore samples of stool and blood serum will be sampled from patients with 2 or 3 consecutive spontaneous abortions and from patients with no abortions or premature birth and at least one pregnancy without complications. Microbiome analyses will be performed on the stool samples, the bloodserum will be used to analyze bacterial metabolic products.
In this study 60 non-pregnant women will be included. 20 women with at least one complication-free pregnancy and no abortions or premature birth in medical history and 40 non-pregnant women with two or three recurrent spontaneous abortions in medical history.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient of the fertility center of the university hospital Tübingen
- •2 or 3 spontaneous abortions in medical history
排除标准
- •Age under 18 years, age over 40 years
- •Current pregnancy
- •Immunosuppressive therapy
- •Antibiotic therapy up to four weeks before admission
- •Acute infection
- •Orale intake of probiotics up to four weeks before admission
结局指标
主要结局
Intestinal microbiome
时间窗: 48 month
Microbiome Analysis from the stool samples
Hormon levels
时间窗: 48 month
Hormone levels of Estrogen, Progesterone from blood and urine samples
bacterial metabolic products
时间窗: 48 month
Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples
次要结局
未报告次要终点
研究者
Dr. Natascha Köstlin-Gille
PD Dr. med. Natascha Köstlin-Gille
University Hospital Tuebingen