Gastrointestinal Symptoms Characteristics and Chinese Medicine Patterns in Patients With Functional Gastrointestinal Disorders (FGIDs) in China: a Multicenter Cross-sectional Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 4632
- Locations
- 1
- Primary Endpoint
- Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Zhong Lidan
Assistant Professor
Hong Kong Baptist University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China
Time Frame: 2 years
The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria
The health-related quality of life (HRQOL) of outpatients with FGIDs in China
Time Frame: 2 years
The HRQOL scale contains 36 questions scoring from 0 to 4. Higher score means a worse outcome. The highest total score is 144.
Secondary Outcomes
- Treatment satisfaction score of CM interventions in outpatients with FGIDs in China(2 years)
- HAMD scoring of outpatients with FGIDs in China(2 years)
- HAMA scoring of outpatients with FGIDs in China(2 years)
- Demographic characteristics of outpatients with FGIDs in China(2 years)
- Quality of life of outpatients with FGIDs in China(2 years)