A Cross-sectional Investigation on Characteristics of Gastrointestinal Symptoms in China

Study Overview
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Brief Summary
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The investigators will conduct a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. In the meanwhile, the investigators will also analyze the characters of CM patterns and corresponding elements, then explore the potential relationship between CM patterns and FGIDs' subtypes.

Detailed Description
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This is a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. Afterwards, the investigators will explore the potential relationship between CM patterns and FGIDs' subtypes based on collected information. It is estimated that 4,632 outpatients from 18 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, education level, marital status, job category, disease course, medical consultation experience, current CM regimens and rationale, and treatment satisfaction. Patients will also complete a series of scales, containing, Rome IV Diagnostic Questionnaire, Patient-Reported Outcome (PRO) scale, the 36-Item Short Form Survey (SF-36), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), lactose food frequency questionnaire (Lactose FFQ) and CM pattern scale. The primary outcome will be the symptom characteristics of outpatients with FGIDs. Secondary outcomes include population characteristics of FGID patients (quality of life, emotional status, lactose intolerance status, and satisfaction level of CM interventions), and potential association between CM patterns and FGIDs' subtypes.

Official Title
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Gastrointestinal Symptoms Characteristics and Chinese Medicine Patterns in Patients With Functional Gastrointestinal Disorders (FGIDs) in China: a Multicenter Cross-sectional Investigation

Conditions
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Functional Gastrointestinal Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms onset at least 3 months Meet the diagnostic criteria of FGIDs Informed consent and ability to read and understand questionnaires Exclusion Criteria: Combined with organic gastrointestinal diseases Appearance of gastrointestinal alarm symptoms Combined with mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China | The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria | 2 years | 
| The health-related quality of life (HRQOL) of outpatients with FGIDs in China | The HRQOL scale contains 36 questions scoring from 0 to 4. Higher score means a worse outcome. The highest total score is 144. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of outpatients with FGIDs in China | Including age, gender, education level, marital status and job categories | 2 years | 
| Quality of life of outpatients with FGIDs in China | 36-Item Short Form Survey (SF-36) will be used. Thirty items are contained and each item is scored on a 0 to 100 range. A high score defines a more favorable health state. | 2 years | 
| HAMA scoring of outpatients with FGIDs in China | Hamilton Anxiety Scale (HAMA) contained and 14 questions scoring form 0 to 4. A high score means a worse anxiety state. | 2 years | 
| HAMD scoring of outpatients with FGIDs in China | Hamilton Depression Scale (HAMD) contained and 17 questions scoring form 0 to 4. A high score means a worse depression state. | 2 years | 
| Treatment satisfaction score of CM interventions in outpatients with FGIDs in China | Treatment satisfaction will be evaluated using a single question scoring from 0 to 4. A higher score means worse satisfaction. | 2 years |