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临床试验/NCT02955316
NCT02955316已完成不适用

Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China

AstraZeneca1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
3,000
试验地点
1
主要终点
IBS prevalence in GI adult outpatients in China

研究概览

简要总结

The primary objective of this study is to estimate the overall prevalence of IBS medically diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.

详细描述

This is a multicentre, nationwide and cross-sectional study carried out in China, covering 30 sites and 3000 patients totally. As for the ratio of tertiary to secondary general hospitals is approximately 1:4 in China, 6 tertiary and 24 secondary hospitals will be randomly selected in this study.To adapt the representativeness of the data with the operational feasibility, 30 tertiary and 120 secondary hospitals will be randomly selected over the 6 geographic regions (north, northeast, east, south central, southwest and northwest). Among those, 1 tertiary and 4 secondary hospitals in each region will be further selected based on GI department setup, willingness to participate in the study, capability and primary investigator's consideration. Within participated hospitals, subjects will be enrolled consecutively from all the outpatients of GI department to minimize selection bias. 3000 subjects will be allocated to tertiary and secondary hospitals with a ratio of 1:1. In general, 250 subjects will be enrolled from tertiary hospitals and 250 subjects will be enrolled from secondary hospitals for each region. During the subject enrolment, the investigator will firstly explain the purpose of the study to consecutive GI patients and written informed consents will be obtained. Then qualified patients will be given a questionnaire and finish it during waiting time. After receiving questionnaires, IBS diagnosis will be made by investigators based on Rome III or Rome IV IBS diagnostic criteria. Subjects will be identified as medically diagnosed with IBS if they have been diagnosed by their clinicians. And subjects will be classified as IBS sufferers without medical diagnosis if they satisfy Rome III or Rome IV diagnostic criteria and have not received IBS diagnosis from physicians. For IBS patients, either medically diagnosed or diagnosed with IBS criteria, investigators will collect all the information on demographic features, disease characteristics and current treatment status. For non-IBS patients, only demographic information will be collected.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Provision of subject informed consent
  • Consecutive female and/or male GI outpatients aged 18 years and over

排除标准

  • Subject with a cognitive condition and unable to finish the questionnaire
  • Subject has an acute or chronic non-GI condition; e.g., doesn't record a 'yes' response to the question, 'Do you have a gut problem?'

结局指标

主要结局

IBS prevalence in GI adult outpatients in China

时间窗: one day

Overall prevalence of IBS medically diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.

次要结局

  • Overall and subgroups' prevalence of medically diagnosed IBS in GI adult outpatients(one day)
  • Assess the current treatment status of IBS outpatients(one day)
  • Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome IV criteria in GI adult patients(one day)
  • Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome III criteria in GI adult patients(one day)
  • Identify disease characteristics of IBS outpatients(one day)
  • Overall and subgroups' prevalence of IBS sufferers in GI adult patients without medical diagnosis(one day)
  • Identify demographic features of IBS and non-IBS outpatients(one day)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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