Effect of Genetic Association With Functional Dyspepsia and Mood Disorders

NCT ID: NCT02282995

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-12-31

Brief 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

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.

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.

Conditions

Dyspepsia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

•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

No interventions assigned to this group

•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

No interventions assigned to this group

•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

No interventions assigned to this group

•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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Justin Che-Yuen Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin C.Y. Wu, MBChB(CUHK)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Justin C.Y. Wu, MBChB(CUHK)

Role: CONTACT

justinwu@cuhk.edu.hk

(852)35053476

Kay Yuen, M Phil

Role: CONTACT

kayyuen@cuhk.edu.hk

(852)35053476

Facility Contacts

Justin C.Y. Wu, MBChB(CUHK)

Role: primary

justinwu@cuhk.edu.hk

(852)35053476

Related Links

http://www.cuhk.edu.hk

The Chinese University of Hong Kong

Other Identifiers

FDFDR

Identifier Type: -

Identifier Source: org_study_id