Helicobacter InfectionsNCT02449941
Helicobacter Pylori and Proton Pump Inhibitor
An observational study of Helicobacter Infections, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- PPI (proton pump inhibitor)
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2016
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample size will be determined based on the analysis the distribution rate of HP at first 30 patients.
Who may be able to join
- Patients who are indicated to endoscopic resection due to gastric neoplasm
- Aged between 19 to 65 years
- Informed consent
Who cannot join
- Previous history of HP eradication
- Previous history of PPI use within 6 months
- No HP infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor
The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.
Read the detailed description
Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.
- Conditions
- Helicobacter Infections
- Being tested
- PPI (proton pump inhibitor)
- Keywords
- Stomach Neoplasms, proton pump inhibitor, endoscopic submucosal dissection, Helicobacter pylori, Gastritis, Atrophic
- Medical subject headings
- Helicobacter Infections, Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI (proton pump inhibitor)Drug
Also called pantoprazole, lansoprazole, dexlansoprazole, rabeprazole
- Pre ESD (endoscopic submucosal dissection)
- Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
- Use of PPI for 2 months
- Post ESD 1 (After 2 months)
- Assess the distribution of helicobacter pylori after using PPI.
- Stop of PPI
- Post ESD 2 (After 4 months)
- Assess the distribution of helicobacter pylori after stop of PPI.
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pylori(HP) positive | Participants who are diagnosed with Helicobacter Pylori infection through ESD(endoscopic submucosal dissection) will be treated with PPI (proton pump inhibitor). Receives: Drug: PPI (proton pump inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor
Measured: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
Secondary outcomes (1)
Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach
Measured: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter InfectionsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yong Ahn, Asan Medical Center
- Investigators
- Ji Yong Ahn, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449941
- Sponsor's protocol ID
- 2014-0341
- Status last verified
- Dec 2016
- First submitted
- 14 May 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gong EJ, Kim DH, Ahn JY, Na HK, Jung KW, Lee JH, Choi KD, Song HJ, Lee GH, Jung HY, Park Y, Kim MJ. Effects of Proton Pump Inhibitor on the Distribution of Helicobacter pylori and Associated Gastritis in Patients with Gastric Atrophy. Digestion. 2020;101(3):279-286. doi: 10.1159/000499424. Epub 2019 May 8.
PubMed 31067538
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor
- ClinicalTrials.gov ID
- NCT02449941
- Acronym / sponsor ID
- 2014-0341
- Conditions
- Helicobacter Infections
- Keywords
- Stomach Neoplasms, proton pump inhibitor, endoscopic submucosal dissection, Helicobacter pylori, Gastritis, Atrophic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 May 2015 (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 purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.
Detailed description
Endoscopy and biopsy will be performed to investigate the distrubition of HP before, during, and after using PPI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori(HP) positive | – | Drug: PPI (proton pump inhibitor)Participants who are diagnosed with Helicobacter Pylori infection through ESD(endoscopic submucosal dissection) will be treated with PPI (proton pump inhibitor). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size will be determined based on the analysis the distribution rate of HP at first 30 patients.
Key inclusion criteria (3 listed)
- Patients who are indicated to endoscopic resection due to gastric neoplasm
- Aged between 19 to 65 years
- Informed consent
Key exclusion criteria (3 listed)
- Previous history of HP eradication
- Previous history of PPI use within 6 months
- No HP infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI (proton pump inhibitor)Also: pantoprazole, lansoprazole, dexlansoprazole, rabeprazole1. Pre ESD (endoscopic submucosal dissection) * Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori * Use of PPI for 2 months 2. Post ESD 1 (After 2 months) * Assess the distribution of helicobacter pylori after using PPI. * Stop of PPI 3. Post ESD 2 (After 4 months) * Assess the distribution of helicobacter pylori after stop of PPI. | Drug | Helicobacter pylori(HP) positive |
Primary outcome
Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor
Time frame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
1 secondary outcome
Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach
Time frame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.
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 6 Dec 2016.
- Derived from this study: PubMed 31067538Gong EJ, Kim DH, Ahn JY, Na HK, Jung KW, Lee JH, Choi KD, Song HJ, Lee GH, Jung HY, Park Y, Kim MJ. Effects of Proton Pump Inhibitor on the Distribution of Helicobacter pylori and Associated Gastritis in Patients with Gastric Atrophy. Digestion. 2020;101(3):279-286. doi: 10.1159/000499424. Epub 2019 May 8.
- Individual participant dataSharing planned: No
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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.
Ji Yong Ahn, Professor principal investigator
Asan Medical Center
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 Infections, run by Asan Medical Center 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 3 inclusion and 3 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 6 Dec 2016. 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?
Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor (time frame: Change in the distribution of Helicobacter Pylori(HP) at 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449941, which also lists 1 linked publication.
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 6 Dec 2016.