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Completed

NCT Number: NCT02173925

Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

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.

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Key information

Conditions

Functional Dyspepsia H. Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Level of fasting plasma acyl ghrelin

    Time frame: Baseline

Secondary outcomes

  1. Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin

    Time frame: Baseline/ 1year

  2. Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With Functional Dyspepsia

Acronym: FD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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