Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

NCT ID: NCT02173925

Last Updated: 2015-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-12-31

Brief Summary

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The pathophysiology of functional dyspepsia is still unclear but several peptides have been indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of appetite and gut motility and serotonin is a typical neurotransmitter related with sensory and motor functions of gut. On the other hand, transient receptor potential vanilloid receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric mucosa of FD patients are different from those in healthy controls, and whether some changes of their expression correlate with certain dyspeptic symptoms. The investigators also investigated the effect of H. pylori infection by comparing their expressions before and one year after H. pylori eradication.

Detailed Description

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Conditions

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Functional Dyspepsia H. Pylori Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Functional dyspepsia group

Patients who had epigastric pain or discomfort with normal upper endoscopy and no organic evidence for explaining these symptoms

No interventions assigned to this group

Control group

Subjects with normal endoscopic finding who do not have any gastrointestinal symptoms

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms

Exclusion Criteria

* Daily user of NSAID or anticoagulants
* with concomitant systemic diseases such as diabetes mellitus or any malignancy
* Participants with major depression, psychosis, eating disorder
* Participants with typical reflux symptom
* Patients with Benign gastric ulcer or duodenal ulcer
* Patients with past gastrointestinal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

M.D, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayoung Kim, M.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1101/119-010

Identifier Type: -

Identifier Source: org_study_id

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