Effect of Genetic Association With Functional Dyspepsia and Mood Disorders (FDFDR)
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Demographic assessment
- Demographic: age, gender
- Anthropometric measurements: body mass index, height, weight
- Smoke and drink habit
- Comorbidity and medical history
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.
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Hong Kong, Hong Kong
- Recrutement
- Prince of Wales Hospital
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Chercheur principal:
- Justin C.Y. Wu, MBChB(CUHK)
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Contact:
- Justin C.Y. Wu, MBChB(CUHK)
- Numéro de téléphone: (852)35053476
- E-mail: justinwu@cuhk.edu.hk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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•FDR-Relatives of FD patients
Relatives of FD patients. Patients may bring at most two FDRs to participate in this study.
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•FDC-Healthy control
Healthy control. Controls who are self-referred to this study will be recruited.
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•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.
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•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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
Délai: up to 48 months
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Differences of genetic polymorphism in targeted genes in patients with FD and mood
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up to 48 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diagnosis of psychiatric disorder with PHQ and HADS
Délai: up to 48 months
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Diagnosis of psychiatric disorder with PHQ and HADS
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up to 48 months
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Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
Délai: up to 48 months
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Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
|
up to 48 months
|
|
Symptom scores
Délai: up to 48 months
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Symptom scores
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up to 48 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Justin C.Y. Wu, MBChB(CUHK), Chinese University of Hong Kong
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FDFDR
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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