Helicobacter PyloriPhase 4NCT02933229
The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
A Phase 4 study testing biopsy and H. pylori eradication in people with Helicobacter Pylori and the Operative Link on Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment
- What is being tested?
- biopsy and H. pylori eradication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with H. pylori infection;
- Aged 18-65 years.
Who cannot join
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
- Pregnancy or breastfeeding;
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies
- Conditions
- Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment
- Being tested
- biopsy, H. pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyDevice
patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.
H. pylori eradicationDrug
- pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin.
If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori eradication cohort | Experimental | H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin.
If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication. Receives: Device: biopsy; Drug: H. pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Measured: 15 years
The proportion of more severe atrophy in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Measured: 15 years
The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Measured: 15 years
Secondary outcomes (2)
The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link on gastritis assessment (OLGA) system compared with original status.
Measured: 15 years
The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link for gastritis intestinal metaplasia (OLGIM) system compared with original status.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933229
- Sponsor's protocol ID
- 2016SDU-QILU-19
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02933229
- Acronym / sponsor ID
- 2016SDU-QILU-19
- Conditions
- Helicobacter Pylori, the Operative Link on Gastric Intestinal Metaplasia, Operative Link on Gastric Intestinal Assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 14 Oct 2016 (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.
Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H. pylori eradication cohort | Experimental | Device: biopsy, Drug: H. pylori eradicationH. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin. If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with H. pylori infection;
- Aged 18-65 years.
Key exclusion criteria (4 listed)
- Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
- Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
- Pregnancy or breastfeeding;
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
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 |
|---|---|---|
| biopsypatients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology. | Device | H. pylori eradication cohort |
| H. pylori eradicationH. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin. If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication. | Drug | H. pylori eradication cohort |
Primary outcome
The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time frame: 15 years
The proportion of more severe atrophy in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time frame: 15 years
The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status
Time frame: 15 years
2 secondary outcomes
The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link on gastritis assessment (OLGA) system compared with original status.
Time frame: 15 years
The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link for gastritis intestinal metaplasia (OLGIM) system compared with original status.
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- 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.
Li Yanqing, MD, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biopsy and H. pylori eradication in people with Helicobacter Pylori and the Operative Link on Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
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 4 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: opening soon, as of the sponsor's last update on 14 Oct 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Yanqing, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status (time frame: 15 years). The study lists 3 primary outcomes in all. 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 14 Oct 2016.