Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

Completed

• Conditions: H. Pylori Infection; Functional Dyspepsia

• Registration Number: NCT02173925
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-05
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of fasting plasma acyl ghrelin	Baseline

Secondary Outcome Measures

Name	Time	Method
Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin	Baseline
Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin	Baseline/ 1year

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of