Clinical trial NCT02955316: Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China
Official title: Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: gastroenterological adult outpatients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject with a cognitive condition and unable to finish the questionnaire
2. 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?'

Primary outcomes:
measure: IBS prevalence in GI adult outpatients in China
timeFrame: one day
Secondary outcomes:
measure: Overall and subgroups' prevalence of medically diagnosed IBS in GI adult outpatients
timeFrame: one day
measure: Overall and subgroups' prevalence of IBS sufferers in GI adult patients without medical diagnosis
timeFrame: one day
measure: Identify demographic features of IBS and non-IBS outpatients
timeFrame: one day
measure: Identify disease characteristics of IBS outpatients
timeFrame: one day
measure: Assess the current treatment status of IBS outpatients
timeFrame: one day
measure: Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome III criteria in GI adult patients
timeFrame: one day
measure: Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome IV criteria in GI adult patients
timeFrame: one day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Research Site
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaohua Hou, PhD
role: STUDY_CHAIR
References: