Functional DyspepsiaFDNCT02173925
Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia
An observational study of Functional Dyspepsia and H. Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, H. Pylori Infection
- How many people
- 314 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With 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.
- Conditions
- Functional Dyspepsia, H. Pylori Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia group | Patients who had epigastric pain or discomfort with normal upper endoscopy and no organic evidence for explaining these symptoms | |
| Control group | Subjects with normal endoscopic finding who do not have any gastrointestinal symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of fasting plasma acyl ghrelin
Measured: Baseline
Secondary outcomes (2)
Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin
Measured: Baseline/ 1year
Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173925
- Sponsor's protocol ID
- B-1101/119-010
- Acronym
- FD
- Status last verified
- Jan 2015
- First submitted
- 13 Jun 2014
- Last updated
- 7 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02173925
- Acronym / sponsor ID
- FD / B-1101/119-010
- Conditions
- Functional Dyspepsia, H. Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia group | – | –Patients who had epigastric pain or discomfort with normal upper endoscopy and no organic evidence for explaining these symptoms |
| Control group | – | –Subjects with normal endoscopic finding who do not have any gastrointestinal symptoms |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of fasting plasma acyl ghrelin
Time frame: Baseline
2 secondary outcomes
Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin
Time frame: Baseline/ 1year
Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayoung Kim, M.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and H. Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of fasting plasma acyl ghrelin (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.