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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202588
• Other study ID #: NationCor-FGID
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 2022

Study information

• Verified date: January 2022
• Source: Hong Kong Baptist University
• Contact: Sonia Low, BNurse
• Phone: 852-34116523
• Email: soniagoh[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4632
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Locations

Country	Name	City	State
Hong Kong	Linda Zhong	Kowloon Tong	Kowloon

Sponsors (18)

Lead Sponsor

Collaborator

Hong Kong Baptist University

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

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Demographic characteristics of outpatients with FGIDs in China	Including age, gender, education level, marital status and job categories	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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