Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2021-11-01
2022-10-28
Brief Summary
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Detailed Description
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The study will collect results of the ROME IV and the Simplified Diagnosis Tool. Sensitivity and specificity of simplified diagnosis methodology compared with ROME IV will be analysed after all the data has been collected.
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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IBS-C Group
Result of ROME VI marked as 'IBS-C'.
No interventions assigned to this group
Non IBS-C Group
Result of ROME VI marked as 'Non IBS-C'
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Decrease of frequency of bowel movement (\<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
* With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
* Result of ROME VI marked as 'IBS-C'.
Group 2 (non-IBS-C)
* ≥18 years old
* Decrease of frequency of bowel movement (\<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
* With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
* Result of ROME VI marked as 'Non IBS-C'.
Exclusion Criteria
* Individuals have an acute or chronic non-GI condition that can be associated with constipation; e.g., central nervous system cause (Parkinson's disease, spinal cord injury, and multiple sclerosis), pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis.
* Individuals who had been diagnosed with the following organic health problems likely to affect GI symptoms:
* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* cancer anywhere in the GI tract or current infection of the GI tract.
* Pelvic floor dysfunction. (i.e., disease that is not adequately treated or stable with therapy.)
* Any history of colon surgeries.
* Individuals who participate in any interventional study currently.
* Not suitable for the study judged by investigators.
18 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Ruijin Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Henan Provincial People's Hospital
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Peking University First Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Shengjing Hospital
OTHER
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lishou Xiong
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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Research Site
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Zhengzhou, , China
Countries
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Related Links
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Other Identifiers
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D5630R00002
Identifier Type: -
Identifier Source: org_study_id