Helicobacter Pylori InfectionNCT04037904
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
An observational study of Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 490 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Controls and patients with gastric dysplasia or gastric cancer who received esophagogastroduodenoscopy and underwent H. pylori tests
Who may be able to join
- Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
- Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report
Who cannot join
- Subjects with previous eradication treatment for H. pylori
- Subjects with previous gastrectomy
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
We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication
Read the detailed description
- pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Interleukin-1 beta, Gastric H+, K+- APTase
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 |
|---|---|---|
| H. pylori negative group | Subjects who have not have H. pylori infection, and had not receive H. pylori eradication | |
| H. pylorieradicated group | Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-1B and H+,K+-ATPase mRNA expression
Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully.
Gastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startFeb 2006
- Primary completionJan 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037904
- Sponsor's protocol ID
- B-1509/316-302
- Status last verified
- Apr 2023
- First submitted
- 28 Jul 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT04037904
- Acronym / sponsor ID
- B-1509/316-302
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Interleukin-1 beta, Gastric H+, K+- APTase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Jul 2019 (actual)
- 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.
We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication
Detailed description
- pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H. pylori negative group | – | –Subjects who have not have H. pylori infection, and had not receive H. pylori eradication |
| H. pylorieradicated group | – | –Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Controls and patients with gastric dysplasia or gastric cancer who received esophagogastroduodenoscopy and underwent H. pylori tests
Key inclusion criteria (2 listed)
- Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
- Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report
Key exclusion criteria (2 listed)
- Subjects with previous eradication treatment for H. pylori
- Subjects with previous gastrectomy
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
Interleukin-1B and H+,K+-ATPase mRNA expression
Time frame: 1 year
Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully. Gastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy
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 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Helicobacter 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 2 inclusion and 2 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 13 Apr 2023. 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?
Interleukin-1B and H+,K+-ATPase mRNA expression (time frame: 1 year). 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 13 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.