NCT02955316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

November 2, 2016

Last Update Submit

November 6, 2018

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Overall and subgroups' prevalence of medically diagnosed IBS in GI adult 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

  • Identify disease characteristics of IBS outpatients

    one day

  • Assess the current treatment status of IBS outpatients

    one day

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

gastroenterological adult outpatients

You may qualify if:

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

You may not qualify if:

  • 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?'

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Wuhan, Hubei, China

Location

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Xiaohua Hou, PhD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

February 10, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

November 7, 2018

Record last verified: 2018-10

Locations

CN(1)