이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2017년 4월 23일 업데이트: Justin Che-Yuen Wu, Chinese University of Hong Kong

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

연구 개요

상태

알려지지 않은

정황

상세 설명

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.

연구 유형

관찰

등록 (예상)

1200

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Hong Kong, 홍콩
        • 모병
        • Prince of Wales Hospital
        • 수석 연구원:
          • Justin C.Y. Wu, MBChB(CUHK)
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
•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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Differences of genetic polymorphism in targeted genes in patients with FD and mood disorders
기간: up to 48 months
Differences of genetic polymorphism in targeted genes in patients with FD and mood
up to 48 months

2차 결과 측정

결과 측정
측정값 설명
기간
Diagnosis of psychiatric disorder with PHQ and HADS
기간: up to 48 months
Diagnosis of psychiatric disorder with PHQ and HADS
up to 48 months
Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
기간: up to 48 months
Differences of plasma ghrelin and serotonin expression in FD patients and study controls.
up to 48 months
Symptom scores
기간: up to 48 months
Symptom scores
up to 48 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Justin C.Y. Wu, MBChB(CUHK), Chinese University of Hong Kong

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 8월 1일

기본 완료 (예상)

2017년 12월 1일

연구 완료 (예상)

2017년 12월 1일

연구 등록 날짜

최초 제출

2014년 4월 17일

QC 기준을 충족하는 최초 제출

2014년 11월 2일

처음 게시됨 (추정)

2014년 11월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 23일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • FDFDR

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다