Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT02282995
Status:
UNKNOWN
Last Update Posted:
2017-04-25
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Genetic Association With Functional Dyspepsia and Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.\n\nSix ml of blood will be used for detection of plasma ghrelin and serotonin expression by ELISA.\n\nThe 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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-23', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-11-02', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders', 'timeFrame': 'up to 48 months', 'description': 'Differences of genetic polymorphism in targeted genes in patients with FD and mood'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of psychiatric disorder with PHQ and HADS', 'timeFrame': 'up to 48 months', 'description': 'Diagnosis of psychiatric disorder with PHQ and HADS'}, {'measure': 'Differences of plasma ghrelin and serotonin expression in FD patients and study controls.', 'timeFrame': 'up to 48 months', 'description': 'Differences of plasma ghrelin and serotonin expression in FD patients and study controls.'}, {'measure': 'Symptom scores', 'timeFrame': 'up to 48 months', 'description': 'Symptom scores'}]}, 'conditionsModule': {'keywords': ['Functional dyspepsia', 'symptom response'], 'conditions': ['Dyspepsia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cuhk.edu.hk', 'label': 'The Chinese University of Hong Kong'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nFunctional 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.\n\nIndication:\n\nFunctional dyspepsia patients\n\nStudy center(s):\n\nPrince of Wales Hospital, Hong Kong\n\nAims:\n\n* To evaluate genetic factors on development of functional dyspepsia \\& common mood disorders\n* To evaluate genetic factors on the severity of function dyspepsia \\& mood disorders\n* To develop a diagnostic test for classification of functional dyspepsia by plasma ghrelin and serotonin expression\n* To collect sleep data for future use\n* To save blood sample for future retrospective diagnostic or genetic examination\n\nStudy design:\n\nCase-control cross sectional study\n\nNumber of subjects:\n\nTotal of 1200 subjects (300 FD patients + 300 relatives of FD patients FDR) and (300 Controls + 300 FDR)\n\nPatient population:\n\nFunctional dyspepsia patients age 18-60\n\nDuration of study:\n\n1 May 2012 - 30 April 2013\n\nPrimary variable(s):\n\nGenetic polymorphisms of targeted genes, plasma ghrelin and serotonin expression\n\nSecondary variable(s):\n\nFD global symptom assessment and symptom scores\n\nNumber of visits: 1\n\nHypotheses:\n\n* Shared genetic factors contribute to the development of FD and common psychological disorders\n* FD patients contribute to suppression of plasma ghrelin and serotonin expression compared to healthy controls', 'detailedDescription': 'Methods:\n\nAll subjects will participate in (1) Demographic assessment, (2) Questionnaires administration and (3) Blood sample collection. The three steps must be completed within 2 weeks.\n\n1. Demographic assessment\n\n * Demographic: age, gender\n * Anthropometric measurements: body mass index, height, weight\n * Smoke and drink habit\n * Comorbidity and medical history\n2. Questionnaires administration\n\n * 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.\n * 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)\n * Hospital Anxiety and Depression Scale (HADS) for a self administered scale for seven covering depression and seven covering anxiety.\n * Psychological disorder: Patient Health Questionnaire (PHQ) will be used for screening of concomitant psychological disorder such as depression and generalized anxiety disorder.\n * The Epworth Sleepiness Scale, Pittsburgh sleep quality index, and General Sleep Quality Questionnaire to collect sleep data for future use.\n3. Blood sample collection\n\n * Up to 20 ml of fasting blood sample will be collected for study aims 1-4.\n * Fasting glucose test will be performed for FD patients\n * Serology test of Hp status will be performed for healthy volunteers and all FDRs\n\nSubjects 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.\n\nIf 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.\n\nLaboratory work:\n\nNine 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.\n\nSix 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nPatients 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.\n\nStudy 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.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subject\n\n * Age 18-60\n * Provision of written consent\n\nAdditional to FD patient\n\n* Symptoms fulfilling Rome III criteria of functional dyspepsia\n* Negative upper endoscopy (oesophagogastroduodenoscopy or OGD) finding\n\nExclusion Criteria:\n\n* All subject\n\n * History of cancer\n * Diabetes mellitus\n * History of gastric surgery\n * Acid suppressants or medications that affect motility in past 4 weeks\n * Organic disease as cause of dyspepsia (for subjects with dyspeptic symptom)\n\nAdditional to healthy volunteer\n\n• Any gastrointestinal symptoms (including acid regurgitation, heartburn, epigastric pain, bloating sensation, constipation, abdominal pain, diarrhea) in the past 4 weeks\n\nAdditional to FD patient\n\n* Frequent (once or more per week) acid reflux or heartburn symptoms\n* Helicobacter pylori (Hp) infection'}, 'identificationModule': {'nctId': 'NCT02282995', 'acronym': 'FDFDR', 'briefTitle': 'Effect of Genetic Association With Functional Dyspepsia and Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effect of Genetic Association With Functional Dyspepsia and Mood Disorders', 'orgStudyIdInfo': {'id': 'FDFDR'}}, 'armsInterventionsModule': {'armGroups': [{'label': '•FDR-Relatives of FD patients', 'description': 'Relatives of FD patients. Patients may bring at most two FDRs to participate in this study.\n\n* Up to 20 ml of fasting blood sample will be collected\n* Serology test of Hp status will be performed for healthy volunteers and all FDRs'}, {'label': '•FDC-Healthy control', 'description': 'Healthy control. Controls who are self-referred to this study will be recruited.\n\n* Up to 20 ml of fasting blood sample will be collected\n* Fasting glucose test will be performed for FD patients\n* Serology test of Hp status will be performed for healthy volunteers and all FDRs'}, {'label': '•FD-Patients with FD', 'description': '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.\n\n* Up to 20 ml of fasting blood sample will be collected\n* Fasting glucose test will be performed for FD patients'}, {'label': '•FDCR-Relatives of healthy controls', 'description': 'Relatives of healthy controls. Each participating control is required to bring at least one and up to two FDRs to participate in this study.\n\n* Up to 20 ml of fasting blood sample will be collected\n* Serology test of Hp status will be performed for healthy volunteers and all FDRs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Justin C.Y. Wu, MBChB(CUHK)', 'role': 'CONTACT', 'email': 'justinwu@cuhk.edu.hk', 'phone': '(852)35053476'}, {'name': 'Justin C.Y. Wu, MBChB(CUHK)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Justin C.Y. Wu, MBChB(CUHK)', 'role': 'CONTACT', 'email': 'justinwu@cuhk.edu.hk', 'phone': '(852)35053476'}, {'name': 'Kay Yuen, M Phil', 'role': 'CONTACT', 'email': 'kayyuen@cuhk.edu.hk', 'phone': '(852)35053476'}], 'overallOfficials': [{'name': 'Justin C.Y. Wu, MBChB(CUHK)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Justin Che-Yuen Wu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}