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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02282995
Other study ID # FDFDR
Secondary ID
Status Recruiting
Phase N/A
First received April 17, 2014
Last updated April 23, 2017
Start date August 2012
Est. completion date December 2017

Study information

Verified date April 2017
Source Chinese University of Hong Kong
Contact Justin C.Y. Wu, MBChB(CUHK)
Phone (852)35053476
Email justinwu@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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