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临床试验/NCT02649374
NCT02649374已完成不适用

Gut Microbiome and Gestational Diabetes Mellitus

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Bacterial population diversity

研究概览

简要总结

The purpose of this study is to document the gut microbiome in the 1st, 2nd and 3rd trimester among pregnant women with gestational diabetes and non diabetic controls.

详细描述

The gut microbiome:

The human body is colonized by a multitude of microorganisms whose collective genome, the microbiome, complements and enhances our own genome. From this perspective, humans are "supra-organisms" colonized by a number of microbial cells that is 10 times greater than the sum of all our human somatic and germ cells, and carrying 150 times more genetic information. The intestine contains the largest collection of microbes among all of our body's "habitats". In the colon, for example, bacteria reach densities of 1011 cells per gram of luminal contents. Together, gut microbes form a community, or microbiota, that has a major impact on health through interactions with host cells (including components of the innate and adaptive immune systems), through extraction of nutrients and energy from the diet, and through complex biotransformations of a variety of ingested compounds, including potential carcinogens. One of the main measures tested when analyzing bacterial populations is diversity - identifying the different microbial components in the population, and describing how similar they are to one another (according to phylogeny) both within a sample and between samples.

Changes in the gut microbiome: The majority of gut microbes are generally viewed as beneficial symbionts, but recent work has revealed that the wrong combination of beneficial microbes can be harmful. Shifts in the composition of the microbiome occur at different stages in life, such as childhood, aging, and pregnancy. Changes in the composition (dysbiosis) are also associated with a growing list of diseases, such as obesity, inflammatory bowel disease (IBD), diabetes, metabolic syndrome and others. Such associations raise the question of whether the dysbiosis contributes to, or is, a symptom of the disease. Microbiome transplant experiments have demonstrated a role of the microbiome in several diseases: several phenotypes could be transferred via the microbiota, such as enhanced fat gain, metabolic syndrome, colitis and recently, fecal transplantation from lean human subjects to human subjects with metabolic syndrome was shown to increase insulin sensitivity. Fecal transplantations have also been used successfully to treat IBD patients. Together these transplantation-based studies imply that the specific composition of the microbiota can be an important factor in the onset, and possibly the progression of chronic diseases. Thus, the gut microbiota may be considered, by extension, a factor in host fitness.

Diet and the microbiome: One of the factors that most influences the composition of the microbiome is diet. Changes in diet influence the relative abundance and composition of the microbiota almost immediately, but for these compositional changes to become stable, the dietary change has to be long term. A few examples of recent studies on how the diet impacts the microbiota are mentioned below. In humans, an increase in the ratio of Bacteroidetes/Firmicutes is observed when restricting the calorie/carbohydrate content. Reduced dietary intake of carbohydrates has also been shown to result in decreased concentrations of butyrate producing bacteria. The type and quantity of dietary fat and carbohydrate have also been shown to alter the gut microbiome of people with metabolic syndrome. Other bacteria, Prevotella for example, are associated with high intake of carbohydrates and simple sugars.

A diet high in fiber has been shown to be associated with an increase in Bifidobacterium, Lactobacillus, Enterococcus and Ruminococcus. Ruminococcus was also shown to increase in abundance in subjects on a resistant starch diet. Changes due to diet have also been described in mice. For example, a high fat diet can profoundly alter the composition of the microbiota towards an enrichment of Firmicutes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women at the 1st trimester

排除标准

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • Post Bariatric surgery
  • Any concurrent chronic illness or medication use
  • Any use of hormones or antibiotics within prior 3 months
  • Multiple gestation

研究组 & 干预措施

No GDM, free diet

No Intervention

Women without GDM, for whom diet. exercise are continued regulary without any modifications

Gestational diabetes mellitus

No Intervention

women diagnosed with GDM during pregnancy, either treated by diet or pharmacological therapy

No GDM, Dietary Modifications

Active Comparator

Women without GDM, will be advised and monitored for dietary, Exercise and lifestyle modifications

干预措施: Dietary, Exercise and lifestyle modifications (Behavioral)

结局指标

主要结局

Bacterial population diversity

时间窗: 9 months

It is a descriptive outcome descibint the physiological composition of the gut and oral microbiome. The microbiome population will be quantified by DNA analysis of the samples collected throughout pregnancy from the oral cavity and stool . The precentage of each baceria colonizing the gut and oral cavitiy will be reported

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eran Hadar

Dr

Rabin Medical Center

研究点 (2)

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