Double Blind,Randomized, Controlled Trial on Impact of Oral Probiotic Blend ( Lactobacillus Rhamnosus GG, L. Crispatus LBV88, L. Rhamnosus LBV96, L.Jensenii LBV116 and L. Gasseri LBV150 ) on Pregnancy Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- HOMA-IR value in week 36-40
研究概览
简要总结
The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.
详细描述
Pregnant women aged > 18 years in the < 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study.
After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.
The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area.
Primary target parameter of the study :
HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT)
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
- Double (Participant, Investigator)
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
- •pregnant women aged > 18 years in the < 14 week of pregnancy
- •willing to consume the study product during pregnancy ( V1 to delivery)
- •willingness to abstain from probiotic food and supplements containing probiotics
- •written informed consent
排除标准
- •Any of the following is regarded as a criterion for exclusion from enrollment in the study:
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion
- •Diabetes mellitus
- •Acute metabolic disorder interfering with glucose metabolism
- •Known cancer < 5y ago
- •Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
- •Anus praeter
- •Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
- •Any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system
- •History of active hepatitis B and C
- •History of HIV infection
- •Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
- •Major cognitive or psychiatric disorders
- •Present drug abuse or alcoholism, reformed alcoholic Legal incapacity
结局指标
主要结局
HOMA-IR value in week 36-40
时间窗: measurement between 36-40 week of pregnancy
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
HOMA-IR value in week 24-28
时间窗: measurement between 24-28 week of pregnancy
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
次要结局
未报告次要终点