Evaluation of the Intestinal Microbiome in Obese Children With and Without Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD.
研究概览
简要总结
The goal of this study is to investigate comparisons between the intestinal microbiome in patients with obesity and in patients with obesity and Non-Alcoholic Fatty Liver Disease (NAFLD). With this protocol we hope to better understand how the microbiome of each individual works with disease progression.
详细描述
The goal of this study is to investigate and compare the composition of the intestinal microbiome in patients with obesity only to patients with obesity and Non-Alcoholic Fatty Liver Disease (NAFLD). In addition, we will investigate the relationship between alterations in the intestinal microbiome, immune activation, and the progression of NAFLD to Non-Alcoholic Steatohepatitis (NASH). We hypothesize that alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD. Based on this hypothesis we propose the following aims:
Aim 1. Identify and enroll pediatric cohort with obesity or obesity/NAFLD to study the role of the intestinal microbiome on the development of NAFLD.
- Enroll participants through the NEW Kids program for treatment of pediatric obesity at Children's Hospital of Wisconsin (CHW). Identify and classify participants through initial clinical evaluation, collect clinical metadata, and obtain and process blood and stool samples for analysis. Demonstrate feasibility by showing that participants can be recruited and participate in the specific study protocol.
- Follow study population through nutritional/exercise intervention, with follow up collection of clinical data, stool, and blood samples.
Aim 2. Characterize the intestinal microbiome through quantitative PCR and high throughput sequencing analysis of stool specimens in participants with obesity and obesity/NAFLD.
- Demonstrate feasibility by showing that sampling aliquots from patient fecal samples can be successfully analyzed by proposed methods and yield consistent results for duplicate samples.
- Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity, and choline metabolism.
- Investigate whether intervention (nutritional/exercise) results in longitudinal alterations in the intestinal microbiome.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-18 Years old
- •Willing to consent/undergo necessary procedures
- •Obese (BMI>30)
- •Speak English or Spanish
排除标准
- •any other causes of liver disease
- •any chronic illnesses or life threatening conditions
结局指标
主要结局
Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD.
时间窗: 3 years
次要结局
- Characterize the intestinal microbiome through quantitative analysis of stool samples in participants with obesity and those with obesity and NAFLD.(3 years)
- Characterize inflammatory markers of participants with obesity versus those obese participants that also have NAFLD.(3 years)