Dyspepsia Clinical Trial
— FDFDROfficial title:
Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
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
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 48 months | |
Secondary | Diagnosis of psychiatric disorder with PHQ and HADS | Diagnosis of psychiatric disorder with PHQ and HADS | up to 48 months | |
Secondary | 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. | up to 48 months | |
Secondary | Symptom scores | Symptom scores | up to 48 months |
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