Functional Gastrointestinal DisordersNCT04202588
A Cross-sectional Investigation on Characteristics of Gastrointestinal Symptoms in China
An observational study of Functional Gastrointestinal Disorders, run by Hong Kong Baptist University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- How many people
- 4,632 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to Jan 2022
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients of third-class hospitals across China
Who may be able to join
- Symptoms onset at least 3 months
- Meet the diagnostic criteria of FGIDs
- Informed consent and ability to read and understand questionnaires
Who cannot join
- Combined with organic gastrointestinal diseases
- Appearance of gastrointestinal alarm symptoms
- Combined with mental disorders
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Linda Zhong
Kowloon Tong, Kowloon
Linda Zhong, MD,PhD, 34116523, ldzhong0305@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China
The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria
Measured: 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.
Measured: 2 years
Secondary outcomes (5)
Demographic characteristics of outpatients with FGIDs in China
Including age, gender, education level, marital status and job categories
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,632 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Wuhan Hospital of Traditional Chinese Medicine, Hospital of Shanxi University of Traditional Chinese Medicine, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhejiang Chinese Medical University, Liuzhou Traditional Chinese Medical Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Henan University of Traditional Chinese Medicine, Second Affiliated Hospital of Fujian Traditional Chinese Medical University, Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zhong Lidan, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202588
- Sponsor's protocol ID
- NationCor-FGID
- Status last verified
- Jan 2022
- First submitted
- 25 Nov 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Symptoms Characteristics and Chinese Medicine Patterns in Patients With Functional Gastrointestinal Disorders (FGIDs) in China: a Multicenter Cross-sectional Investigation
- ClinicalTrials.gov ID
- NCT04202588
- Acronym / sponsor ID
- NationCor-FGID
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,632 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Wuhan Hospital of Traditional Chinese Medicine, Hospital of Shanxi University of Traditional Chinese Medicine, First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhejiang Chinese Medical University, Liuzhou Traditional Chinese Medical Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Henan University of Traditional Chinese Medicine, Second Affiliated Hospital of Fujian Traditional Chinese Medical University, Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients of third-class hospitals across China
Key inclusion criteria (3 listed)
- Symptoms onset at least 3 months
- Meet the diagnostic criteria of FGIDs
- Informed consent and ability to read and understand questionnaires
Key exclusion criteria (3 listed)
- Combined with organic gastrointestinal diseases
- Appearance of gastrointestinal alarm symptoms
- Combined with mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Demographic characteristics of outpatients with FGIDs in China
Time frame: 2 years
Quality of life of outpatients with FGIDs in China
Time frame: 2 years
HAMA scoring of outpatients with FGIDs in China
Time frame: 2 years
HAMD scoring of outpatients with FGIDs in China
Time frame: 2 years
Treatment satisfaction score of CM interventions in outpatients with FGIDs in China
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders, run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Low, BNurse (852-34116523, soniagoh@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.