Skip to main content
OpenTrials
Completed

NCT Number: NCT02955316

Irritable Bowel Syndrome Survey in Gastroenterological Adult Outpatients in China

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Wuhan, Hubei, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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?'

Treatment and study plan

Primary outcomes

  1. IBS prevalence in GI adult outpatients in China

    Time frame: one day

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

Secondary outcomes

  1. Overall and subgroups' prevalence of medically diagnosed IBS in GI adult outpatients

    Time frame: one day

    Overall prevalence and prevalence of IBS-C, D, M, U of medically diagnosed IBS adult outpatients.

  2. Overall and subgroups' prevalence of IBS sufferers in GI adult patients without medical diagnosis

    Time frame: one day

    Overall prevalence and prevalence of IBS-C, D, M, U of IBS sufferers in GI adult patients without medical diagnosis

  3. Identify demographic features of IBS and non-IBS outpatients

    Time frame: one day

    Demographic features of IBS and non-IBS outpatients: age, gender, occupation, use of smoking and alcohol, diet, sleeping habit

  4. Identify disease characteristics of IBS outpatients

    Time frame: one day

    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

  5. Assess the current treatment status of IBS outpatients

    Time frame: one day

    Current treatment status: hospital visit frequency, previous medicine use, concomitant medications, treatment efficacy, treatment satisfaction, cost of therapy

  6. Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome III criteria in GI adult patients

    Time frame: one day

    Overall prevalence and prevalence of IBS-C,D,M,U of IBS diagnosed by Rome III criteria in GI adult outpatients in China

  7. Estimate the overall and subgroups' prevalence of IBS diagnosed by Rome IV criteria in GI adult patients

    Time frame: one day

    Overall prevalence and prevalence of IBS-C,D,M,U of IBS diagnosed by Rome IV criteria in GI adult outpatients in China.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: IRONS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.