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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Gastrointestinal Disorders

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.

• Study Type: Observational
• Enrollment (Anticipated): 4632

Contacts and Locations

• Study Contact: Name: Sonia Low, BNurse; Phone Number: 852-34116523; Email: soniagoh@hkbu.edu.hk

Study Locations

• Hong Kong
  • Kowloon
    • Kowloon Tong, Kowloon, Hong Kong
      • Recruiting
      • Linda Zhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients of third-class hospitals across China

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Xiyuan Hospital of China Academy of Chinese Medical Sciences; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Shanghai University of Traditional Chinese Medicine; Shaanxi Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Zhejiang Chinese Medical University; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Wuhan Hospital of Traditional Chinese Medicine; Jiangsu Province Hospital of Chinese Medicine; Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine; Hospital of Shanxi University of Traditional Chinese Medicine; First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine; Liuzhou Traditional Chinese Medical Hospital; Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University; Henan University of Chinese Medicine; Second Affiliated Hospital of Fujian Traditional Chinese Medical University; Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: NationCor-FGID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No