DyspepsiaFDFDRNCT02282995
Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
An observational study of Dyspepsia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter pylori infection, etc. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- How many people
- 1,200 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2012to Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID or who participated in PI's previous clinical trials will be invited to participate in this study as FD patients. Patients not suffering from FGID will be identified from the gastrointestinal specialty clinic or Endoscopy Center, Prince of Wales Hospital as healthy volunteers. These patients may include those referred for GI malignancy screening. Study advertisement will be posted in public area of Prince of Wales Hospital, and on the educational website (www.digestion.hk) which is maintained by PI. Controls who are self-referred to this study will be recruited.
Who may be able to join
- All subject
- Age 18-60
- Provision of written consent
- Additional to FD patient
- Symptoms fulfilling Rome III criteria of functional dyspepsia
- Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding
Who cannot join
- All subject
- History of cancer
- Diabetes mellitus
- History of gastric surgery
- Acid suppressants or medications that affect motility in past 4 weeks
- Organic disease as cause of dyspepsia (for subjects with dyspeptic symptom)
Show all 11Show fewer
- Additional to healthy volunteer
- Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain, bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks
- Additional to FD patient
- Frequent (once or more per week) acid reflux or heartburn symptoms
- Helicobacter pylori (Hp) infection
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Justin C.Y. Wu, MBChB(CUHK), (852)35053476, justinwu@cuhk.edu.hk
Justin C.Y. Wu, MBChB(CUHK)
About this study
Background:
Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter pylori infection, etc. However, few reported the association of genetic contribution to the development of FD and mood disorder.
Read more
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims:
- To evaluate genetic factors on development of functional dyspepsia \& common mood disorders
- To evaluate genetic factors on the severity of function dyspepsia \& mood disorders
- To develop a diagnostic test for classification of functional dyspepsia by plasma ghrelin and serotonin expression
- To collect sleep data for future use
- To save blood sample for future retrospective diagnostic or genetic examination
Study design:
Case-control cross sectional study
Number of subjects:
Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls + 300 FDR)
Patient population:
Functional dyspepsia patients age 18-60
Duration of study:
1 May 2012 - 30 April 2013
Primary variable(s):
Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression
Secondary variable(s):
FD global symptom assessment and symptom scores
Number of visits: 1
Hypotheses:
- Shared genetic factors contribute to the development of FD and common psychological disorders
- FD patients contribute to suppression of plasma ghrelin and serotonin expression compared to healthy controls
Read the detailed description
Methods:
All subjects will participate in (1) Demographic assessment, (2) Questionnaires administration and (3) Blood sample collection. The three steps must be completed within 2 weeks.
- Demographic assessment
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight
- Smoke and drink habit
- Comorbidity and medical history
- Questionnaires administration
- A combined functional gastrointestinal (GI) symptom questionnaire (FGISQ) based on recall of the past 7 days will be used for assessment all GI symptoms including regurgitation, heartburn, epigastric pain, postprandial fullness, abdominal pain, diarrhea, constipation etc. All questions use a 4-point (0-3) Likert scale.
- FGI Screening Questionnaire (v.3, 20101011) for screening of functional gastrointestinal disorder according to Rome III criteria. The questionnaire incorporate a GERD diagnostic questionnaire GERDQ (Chinese version)
- Hospital Anxiety and Depression Scale (HADS) for a self administered scale for seven covering depression and seven covering anxiety.
- Psychological disorder: Patient Health Questionnaire (PHQ) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.
- The Epworth Sleepiness Scale, Pittsburgh sleep quality index, and General Sleep Quality Questionnaire to collect sleep data for future use.
- Blood sample collection
- Up to 20 ml of fasting blood sample will be collected for study aims 1-4.
- Fasting glucose test will be performed for FD patients
- Serology test of Hp status will be performed for healthy volunteers and all FDRs
Subjects who had fasting glucose test or serology test performed within one year before study enrollment can be exempted from repeating the tests if they refuse to repeat the tests. In such cases, their previous test results will be recorded and used in this study.
If the subjects are found to be positive as a result of Helicobacter pylori (Hp) serology test, a referral letter with prescription suggestion will be given to the subjects to seek proper medical care in the primary care setting. In current practice, Hp eradication is not mandatory for asymptomatic subjects.
Laboratory work:
Nine ml of blood will be used for the detection of biomarkers for functional dyspepsia through single nucleotide polymorphism (SNPs). The genotyping DNA will be isolated from whole blood samples by (FlexGene DNA kit, Qiagen). High-throughput genotyping will be performed on the serotonin 3A receptor polymorphism (rs1062613) and ghrelin CLOCK 3111C polymorphism (rs1801260). It will be analyzed by Applied Biosystems (ABI) 3730xl DNA Analyzer.
Six ml of blood will be used for detection of plasma ghrelin and serotonin expression for development of diagnostic test in classification of functional dyspepsia by ELISA.
- Conditions
- Dyspepsia
- Keywords
- Functional dyspepsia, symptom response
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| •FDR-Relatives of FD patients | Relatives of FD patients. Patients may bring at most two FDRs to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs | |
| •FDC-Healthy control | Healthy control. Controls who are self-referred to this study will be recruited. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients * Serology test of Hp status will be performed for healthy volunteers and all FDRs | |
| •FD-Patients with FD | Patients with FD. Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID will be invited to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients | |
| •FDCR-Relatives of healthy controls | Relatives of healthy controls. Each participating control is required to bring at least one and up to two FDRs to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
Differences of genetic polymorphism in targeted genes in patients with FD and mood
Measured: up to 48 months
Secondary outcomes (3)
Diagnosis of psychiatric disorder with PHQ and HADS
Diagnosis of psychiatric disorder with PHQ and HADS
Measured: up to 48 months
Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
Measured: up to 48 months
Symptom scores
Symptom scores
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Che-Yuen Wu, Chinese University of Hong Kong
- Investigators
- Justin C.Y. Wu, MBChB(CUHK), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282995
- Sponsor's protocol ID
- FDFDR
- Acronym
- FDFDR
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
- ClinicalTrials.gov ID
- NCT02282995
- Acronym / sponsor ID
- FDFDR / FDFDR
- Conditions
- Dyspepsia
- Keywords
- Functional dyspepsia, symptom response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- 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.
Background:
Functional dyspepsia (FD) is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Risk factors include genetics, gender, age, helicobacter pylori infection, etc. However, few reported the association of genetic contribution to the development of FD and mood disorder.
Indication:
Functional dyspepsia patients
Study center(s):
Prince of Wales Hospital, Hong Kong
Aims:
- To evaluate genetic factors on development of functional dyspepsia \& common mood disorders
- To evaluate genetic factors on the severity of function dyspepsia \& mood disorders
- To develop a diagnostic test for classification of functional dyspepsia by plasma ghrelin and serotonin expression
- To collect sleep data for future use
- To save blood sample for future retrospective diagnostic or genetic examination
Study design:
Case-control cross sectional study
Number of subjects:
Total of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls + 300 FDR)
Patient population:
Functional dyspepsia patients age 18-60
Duration of study:
1 May 2012 - 30 April 2013
Primary variable(s):
Genetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression
Secondary variable(s):
FD global symptom assessment and symptom scores
Number of visits: 1
Hypotheses:
- Shared genetic factors contribute to the development of FD and common psychological disorders
- FD patients contribute to suppression of plasma ghrelin and serotonin expression compared to healthy controls
Detailed description
Methods:
All subjects will participate in (1) Demographic assessment, (2) Questionnaires administration and (3) Blood sample collection. The three steps must be completed within 2 weeks.
- Demographic assessment
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight
- Smoke and drink habit
- Comorbidity and medical history
- Questionnaires administration
- A combined functional gastrointestinal (GI) symptom questionnaire (FGISQ) based on recall of the past 7 days will be used for assessment all GI symptoms including regurgitation, heartburn, epigastric pain, postprandial fullness, abdominal pain, diarrhea, constipation etc. All questions use a 4-point (0-3) Likert scale.
- FGI Screening Questionnaire (v.3, 20101011) for screening of functional gastrointestinal disorder according to Rome III criteria. The questionnaire incorporate a GERD diagnostic questionnaire GERDQ (Chinese version)
- Hospital Anxiety and Depression Scale (HADS) for a self administered scale for seven covering depression and seven covering anxiety.
- Psychological disorder: Patient Health Questionnaire (PHQ) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.
- The Epworth Sleepiness Scale, Pittsburgh sleep quality index, and General Sleep Quality Questionnaire to collect sleep data for future use.
- Blood sample collection
- Up to 20 ml of fasting blood sample will be collected for study aims 1-4.
- Fasting glucose test will be performed for FD patients
- Serology test of Hp status will be performed for healthy volunteers and all FDRs
Subjects who had fasting glucose test or serology test performed within one year before study enrollment can be exempted from repeating the tests if they refuse to repeat the tests. In such cases, their previous test results will be recorded and used in this study.
If the subjects are found to be positive as a result of Helicobacter pylori (Hp) serology test, a referral letter with prescription suggestion will be given to the subjects to seek proper medical care in the primary care setting. In current practice, Hp eradication is not mandatory for asymptomatic subjects.
Laboratory work:
Nine ml of blood will be used for the detection of biomarkers for functional dyspepsia through single nucleotide polymorphism (SNPs). The genotyping DNA will be isolated from whole blood samples by (FlexGene DNA kit, Qiagen). High-throughput genotyping will be performed on the serotonin 3A receptor polymorphism (rs1062613) and ghrelin CLOCK 3111C polymorphism (rs1801260). It will be analyzed by Applied Biosystems (ABI) 3730xl DNA Analyzer.
Six ml of blood will be used for detection of plasma ghrelin and serotonin expression for development of diagnostic test in classification of functional dyspepsia by ELISA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| •FDR-Relatives of FD patients | – | –Relatives of FD patients. Patients may bring at most two FDRs to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs |
| •FDC-Healthy control | – | –Healthy control. Controls who are self-referred to this study will be recruited. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients * Serology test of Hp status will be performed for healthy volunteers and all FDRs |
| •FD-Patients with FD | – | –Patients with FD. Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID will be invited to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Fasting glucose test will be performed for FD patients |
| •FDCR-Relatives of healthy controls | – | –Relatives of healthy controls. Each participating control is required to bring at least one and up to two FDRs to participate in this study. * Up to 20 ml of fasting blood sample will be collected * Serology test of Hp status will be performed for healthy volunteers and all FDRs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients referred for OGD in Endoscopy Center, Prince of Wales Hospital, with symptoms suggestive of FGID or who participated in PI's previous clinical trials will be invited to participate in this study as FD patients. Patients not suffering from FGID will be identified from the gastrointestinal specialty clinic or Endoscopy Center, Prince of Wales Hospital as healthy volunteers. These patients may include those referred for GI malignancy screening. Study advertisement will be posted in public area of Prince of Wales Hospital, and on the educational website (www.digestion.hk) which is maintained by PI. Controls who are self-referred to this study will be recruited.
Key inclusion criteria (6 listed)
- All subject
- Additional to FD patient
- Symptoms fulfilling Rome III criteria of functional dyspepsia
- Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding
Key exclusion criteria (11 listed)
- All subject
- Additional to healthy volunteer
- Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain, bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks
- Additional to FD patient
- Frequent (once or more per week) acid reflux or heartburn symptoms
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
Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
Time frame: up to 48 months
Differences of genetic polymorphism in targeted genes in patients with FD and mood
3 secondary outcomes
Diagnosis of psychiatric disorder with PHQ and HADS
Time frame: up to 48 months
Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
Time frame: up to 48 months
Symptom scores
Time frame: up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- The Chinese University of Hong KongLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Justin C.Y. Wu, MBChB(CUHK) principal investigator
Chinese University of Hong Kong
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 Dyspepsia, run by Chinese University of Hong Kong 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 6 inclusion and 11 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 25 Apr 2017. 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 Justin C.Y. Wu, MBChB(CUHK) ((852)35053476, justinwu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders (time frame: up to 48 months). 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 25 Apr 2017.