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临床试验/NCT02822677
NCT02822677已完成不适用

The Distribution of Irritable Bowel Syndrome (IBS) Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions Associated With IBS Subtypes

Hong Kong Baptist University1 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2016年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
504
试验地点
1
主要终点
the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.

研究概览

简要总结

The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes.

详细描述

It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes. The primary outcome will be the distribution of IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship between CM pattern and their microbiota and metabolic profiling. The relationship between IBS subtype distribution and other predetermined factors will be assessed, including gender, age, weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview for DSM-5 Disorders-(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed. After the collection of serum, urine and stool samples, bacterial total DNA will be extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA and BA profiles in serum and feces will be tested as well.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meet of diagnosis of IBS(ROME 4); 2) age of 18 to 65 years (inclusive); 3) IBS Symptom Severity Scale [17] (IBS-SSS) > 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period; 4) Normal colonic evaluation (colonoscopy or barium enema) within 5 years; 5) Written informed consent.

排除标准

  • pregnancy or breast-feeding; 2) medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases; 3) Having suicidal ideas or attempts or aggressive behavior; 4) Use of medications known to influence gastrointestinal transit.

结局指标

主要结局

the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.

时间窗: one year

次要结局

  • the Host-gut Microbiota Metabolic Interactions Associated with IBS Subtypes(one year)
  • the relationship between CM pattern and metabolic profiling(one year)
  • the Relationship Between CM Pattern and Their Microbiota(one year)

研究者

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

ZhaoXiang Bian

Chair Professor

Hong Kong Baptist University

研究点 (1)

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