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Trial record 5 of 39 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

Effect of Genetic Association With Functional Dyspepsia and Mood Disorders (FDFDR)

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ClinicalTrials.gov Identifier: NCT02282995
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong

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

Condition or disease
Dyspepsia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
Study Start Date : August 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
•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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Diagnosis of psychiatric disorder with PHQ and HADS [ Time Frame: up to 48 months ]
    Diagnosis of psychiatric disorder with PHQ and HADS

  2. Differences of plasma ghrelin and serotonin expression in FD patients and study controls. [ Time Frame: up to 48 months ]
    Differences of plasma ghrelin and serotonin expression in FD patients and study controls.

  3. Symptom scores [ Time Frame: up to 48 months ]
    Symptom scores


Biospecimen Retention:   Samples With DNA

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 by ELISA.

The remaining blood samples will be stored in the Laboratory of Institute of Digestive Diseases for tests stated in the Aim section, also for future studies for emerging diseases related to FGID.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282995


Contacts
Contact: Justin C.Y. Wu, MBChB(CUHK) (852)35053476 justinwu@cuhk.edu.hk
Contact: Kay Yuen, M Phil (852)35053476 kayyuen@cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Justin C.Y. Wu, MBChB(CUHK)    (852)35053476    justinwu@cuhk.edu.hk   
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK)         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) Chinese University of Hong Kong

Additional Information:
Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02282995     History of Changes
Other Study ID Numbers: FDFDR
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Functional dyspepsia
symptom response

Additional relevant MeSH terms:
Dyspepsia
Mood Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders