Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China

Irritable Bowel Syndrome (IBS) Clinical Trial

— IRONS  

Official title:

Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955316
• Other study ID #: D1844R00004
• Status: Completed
• Start date: February 10, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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?'

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Locations

Country	Name	City	State
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS prevalence in GI adult outpatients in China	Overall prevalence of IBS medically diagnosed and diagnosed using Rome III or IV criteria in GI adult outpatients in China.	one day
Secondary	Overall and subgroups' prevalence of medically diagnosed IBS in GI adult outpatients	Overall prevalence and prevalence of IBS-C, D, M, U of medically diagnosed IBS adult outpatients.	one day
Secondary	Overall and subgroups' prevalence of IBS sufferers in GI adult patients without medical diagnosis	Overall prevalence and prevalence of IBS-C, D, M, U of IBS sufferers in GI adult patients without medical diagnosis	one day
Secondary	Identify demographic features of IBS and non-IBS outpatients	Demographic features of IBS and non-IBS outpatients: age, gender, occupation, use of smoking and alcohol, diet, sleeping habit	one day
Secondary	Identify disease characteristics of IBS outpatients	Disease characteristics of IBS outpatients: reason for visit to clinic, time of symptoms occur and diagnosis, previous diagnosis, bothersomeness of symptoms, frequency of symptoms, severity of symptoms, absence of work	one day
Secondary	Assess the current treatment status of IBS outpatients	Current treatment status: hospital visit frequency, previous medicine use, concomitant medications, treatment efficacy, treatment satisfaction, cost of therapy	one day
Secondary	Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome III criteria in GI adult patients	Overall prevalence and prevalence of IBS-C,D,M,U of IBS diagnosed by Rome III criteria in GI adult outpatients in China	one day
Secondary	Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome IV criteria in GI adult patients	Overall prevalence and prevalence of IBS-C,D,M,U of IBS diagnosed by Rome IV criteria in GI adult outpatients in China.	one day

External Links

•   D1844R00004 CSR synopsis