Helicobacter PyloriPhase 4NCT05790525
Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
A Phase 4 study testing Standard bismuth quadruple in people with Helicobacter Pylori, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Standard bismuth quadruple
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 1 Nov 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18~70 ,both gender.
- Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
- Have not received dental care or systemic periodontal basic treatment in the past 1 year.
Who cannot join
- Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
- There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
- Those with severe oral diseases and malignant tumors of the mouth.
- Women planning pregnancy, pregnancy and breastfeeding.
- Previously had upper gastrointestinal surgery.
- Those who do not take their medication on time.
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.
- Conditions
- Helicobacter Pylori
- Being tested
- Standard bismuth quadruple
- Keywords
- Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard bismuth quadrupleDrug
Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines
| Study group | Role | What they receive |
|---|---|---|
| Both gastric and oral Helicobacter pylori are positive | Other | Not described Receives: Drug: Standard bismuth quadruple |
| Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity | Other | Not described Receives: Drug: Standard bismuth quadruple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori in the stomach
The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative
Measured: 28 days after treatment
Secondary outcomes (1)
Oral Helicobacter pylori conversion rate
Oral Helicobacter pylori conversion rate 28 days after treatment
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start22 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Yongquan Shi, PhD, Study director, Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790525
- Sponsor's protocol ID
- KY20232027-C-1-B
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT05790525
- Acronym / sponsor ID
- KY20232027-C-1-B
- Conditions
- Helicobacter Pylori
- Keywords
- Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 30 Mar 2023 (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.
The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Both gastric and oral Helicobacter pylori are positive | Other | Drug: Standard bismuth quadruple |
| Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity | Other | Drug: Standard bismuth quadruple |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18~70 ,both gender.
- Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
- Have not received dental care or systemic periodontal basic treatment in the past 1 year.
Key exclusion criteria (8 listed)
- Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
- There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
- Those with severe oral diseases and malignant tumors of the mouth.
- Women planning pregnancy, pregnancy and breastfeeding.
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 |
|---|---|---|
| Standard bismuth quadrupleUse the standard bismuth quadruple regimen recommended by the latest Chinese guidelines | Drug | Both gastric and oral Helicobacter pylori are positive, Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity |
Primary outcome
Eradication rate of Helicobacter pylori in the stomach
Time frame: 28 days after treatment
The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative
1 secondary outcome
Oral Helicobacter pylori conversion rate
Time frame: 28 days after treatment
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 3 Jul 2025.
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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.
Yongquan Shi, PhD study director
Xijing Hosipital of Digestive Disease
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 Standard bismuth quadruple in people with Helicobacter Pylori, run by Xijing Hospital of Digestive Diseases 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 3 inclusion and 8 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 3 Jul 2025. 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?
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?
Eradication rate of Helicobacter pylori in the stomach (time frame: 28 days after treatment). 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 3 Jul 2025.