Clinical trial NCT04202588: A Cross-sectional Investigation on Characteristics of Gastrointestinal Symptoms in China
Official title: Gastrointestinal Symptoms Characteristics and Chinese Medicine Patterns in Patients With Functional Gastrointestinal Disorders (FGIDs) in China: a Multicenter Cross-sectional Investigation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Wuhan Hospital of Traditional Chinese Medicine
name: Hospital of Shanxi University of Traditional Chinese Medicine
name: First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Liuzhou Traditional Chinese Medical Hospital
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University
name: Henan University of Chinese Medicine
name: Second Affiliated Hospital of Fujian Traditional Chinese Medical University
name: Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
First posted: 2019-12-17
Enrollment: 4632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients of third-class hospitals across China

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.

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

Primary outcomes:
measure: Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China
timeFrame: 2 years
measure: The health-related quality of life (HRQOL) of outpatients with FGIDs in China
timeFrame: 2 years
Secondary outcomes:
measure: Demographic characteristics of outpatients with FGIDs in China
timeFrame: 2 years
measure: Quality of life of outpatients with FGIDs in China
timeFrame: 2 years
measure: HAMA scoring of outpatients with FGIDs in China
timeFrame: 2 years
measure: HAMD scoring of outpatients with FGIDs in China
timeFrame: 2 years
measure: Treatment satisfaction score of CM interventions in outpatients with FGIDs in China
timeFrame: 2 years
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
References: