Clinical trial NCT02173925: Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia
Official title: Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Dyspepsia
H. Pylori Infection
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had epigastric pain or discomfort with normal upper endoscopy and no evidence for explaining these symptoms were prospectively enrolled in Seoul National University Bundang Hospital. All participants underwent esophagogastroduodenoscopy. During endoscopy, biopsies were taken from both antrum and body for histological evaluation, determining H. pylori infection status.

Participants were divided into control and patients according to the Rome III criteria. Patients group were subclassified into 3 categories; PDS (postprandial distress syndrome), EPS(epigastric pain syndrome) or mixed (PDS+EPS)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of fasting plasma acyl ghrelin
timeFrame: Baseline
Secondary outcomes:
measure: Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin
timeFrame: Baseline/ 1year
measure: Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin
timeFrame: Baseline
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References: