Dyspepsia Clinical Trial
Official 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
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.
1. Demographic assessment
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight
- Smoke and drink habit
- Comorbidity and medical history
2. 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.
3. 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.
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