Helicobacter Pylori InfectionHpNCT05455372
Influence of Oral Hp Infection and Oral Related Factors on Gastric Hp Infection and Eradication Therapy
A study testing PPI quadruple therapy in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) is closely related to the occurrence of gastric cancer and other diseases. The discovery and eradication of H. pylori is of great significance for the prevention and treatment of related diseases. Oral H. pylori may act as a "reservoir" to cause H. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PPI quadruple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to 31 Mar 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The first stage:Study the prevalence and risk factors of oral and gastric H. pylori infection 1. No obstacle to understanding the content of the questionnaire, and can answer the questions accurately, 2. Voluntarily participate in this research and sign the informed consent. The second stage:Study the status and influencing factors of eradication therapy of oral and gastric H. pylori
- >18 years old,
- Initial H. pylori eradication therapy,
- No obstacle to understanding the content of the questionnaire, and can answer the questions accurately,
- Agree to perform eradication treatment and receive telephone follow-up, and sign the informed consent.
Who cannot join
- The first stage:Study the prevalence and risk factors of oral and gastric H. pylori infection
- History of taking proton pump inhibitors (PPI), H2 receptor blockers and bismuth agent within two weeks before enrollment,
- History of taking antibiotics and Chinese medicines with antibacterial effect within one month before enrollment,
- Complete or partial gastrectomy,
- Edentulous. The second stage:Study the status and influencing factors of eradication therapy of oral and gastric H. pylori
- 1. Allergic to penicillin, clarithromycin, ilaprazole, colloidal bismuth tartrate, 2. Complete or partial gastrectomy, 3. Oral scaling within 6 months, 4. Edentulous.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Xi'an Jiaotong university
Xi'an, Shaanxi, 710004
Ping Zhao, MD, 13659287149, peggyzhao@163.com
About this study
Official title: Analysis of Influencing Factors of Oral Helicobacter Pylori Infection and Oral Related Factors on Gastric Helicobacter Pylori Infection and Eradication Therapy Among the Outpatients of A Tertiary Hospital in Xi'an
Helicobacter pylori (H. pylori) is closely related to the occurrence of gastric cancer and other diseases. The discovery and eradication of H. pylori is of great significance for the prevention and treatment of related diseases. Oral H. pylori may act as a "reservoir" to cause H. pylori to spread between populations and to cause individual gastric H. pylori infection and recurrence.Understanding the oral and gastric H. pylori infection and influencing factors of the population can provide scientific basis for the formulation of local H. pylori infection prevention strategies.Analyzing the influencing factors of H. pylori eradication in the population can improve the local H. pylori eradication rate and reduce the recurrence of H. pylori infection.Therefore, this study intends to analyze the influence of oral H. pylori infection and oral related factors on gastric H. pylori infection and eradication therapy in outpatients of a tertiary hospital in Xi'an.
Read the detailed description
Taking 300 dyspepsia patients who will undergo C13-urea breath test (C13-UBT) in the outpatient department of gastroenterology of the Second Affiliated Hospital of Xi'an Jiaotong University from July 2022 to March 2024 as the research subjects. A questionnaire survey on factors related to H. pylori infection will be conducted,which include basic information, eating habits, living environment, and oral care habits.From July 2022 to March 2024, Taking 300 patients who will be diagnosed with gastric H. pylori infection in the Gastroenterology Department of the Second Affiliated Hospital of Xi'an Jiaotong University and receive bismuth quadruple H. pylori eradication therapy as the research subjects.The bismuth quadruple regimen is specifically ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.The research subjects will be also required to complete a questionnaire survey on factors related to the eradication therapy of gastric H. pylori,the contents of the questionnaire include basic information, living habits, side effects of medication, and compliance.All the above populations will be given H. pylori Saliva Test Cassette (HPS) to detect whether H. pylori infection in the oral cavity, and the oral hygiene score (OHI) and the permanent tooth decay missing fill index (DMF) will be also evaluated and recorded.4-6 weeks after the end of treatment, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication, and the oral H. pylori infection will be re-detected by HPS.The patients with successful eradication therapy of gastric H. pylori will be followed up, and the recurrence of gastric H. pylori will be confirmed by 13C-UBT 1 year later.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PPI quadruple therapy
- Keywords
- Helicobacter pylori, Oral hygiene, Dental caries, Risk factor, Saliva Test Cassette
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI quadruple therapyDrug
PPI quadruple therapy refers to ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid.
| Study group | Role | What they receive |
|---|---|---|
| oral H. pylori negative and gastric H. pylori negative group | No intervention | These people are tested negative for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS). |
| oral H. pylori positive and gastric H. pylori negative group | No intervention | These people are tested negative for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS). |
| oral H. pylori negative and gastric H. pylori positive group | Experimental | These patients are tested positive for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS),they are given PPI quadruple therapy for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication.At the same time, Patients with successful eradication will be instructed to conduct 13C-UBT examination after 1year to confirm whether the recurrence of gastric H. pylori. Receives: Drug: PPI quadruple therapy |
| oral H. pylori positive and gastric H. pylori positive group | Experimental | These patients are tested positive for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS),they are given PPI quadruple therapy for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication, and the oral H. pylori infection will be re-detected by HPS.At the same time, Patients with successful eradication will be instructed to conduct 13C-UBT examination after 1year to confirm whether the recurrence of gastric H. pylori. Receives: Drug: PPI quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral and gastric H. pylori infection rate
The gastric infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing 13-UBT,The oral infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing HPS.(On the 13-UBT,if the result DOB≥4. 0‰, it can be determined that the subject is gastric H. pylori positive; DOB <4. 0‰,the subject is gastric H. pylori negative.On the HPS,If the T line and C line appear, it is judged to be positive for oral H. pylori infection, but if the C line appears, it is judged to be negative for oral H. pylori infection. If the C line does not appear, it is an invalid test result and needs to be re-tested.)
Measured: 1 year
The affecting factors of oral and gastric H. pylori infection.
Questionnaire used in this study refers to"National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Oral hygiene is assessed using the Simplified Oral Hygiene Index (OHI-S), which is the sum of the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S).Dental caries is measured by the decay missing fill index (DMF),which refers to the sum of caries, lost and filled teeth.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between oral and gastric H. pylori infection and the factors.
Measured: 1 year
Oral and gastric H. pylori eradication rate
The gastric H. pylori positive patients receive PPI quadruple therapy,and after 4-6 weeks of completing eradication therapy, 13C-UBT and HPS are performed.The gastric H. pylori eradication rate is defined as the ratio of the number of subjects who become negative through 13C-UBT after taking the eradication drug to the number of all subjects who take the eradication drug.The oral H. pylori eradication rate is defined as the proportion of subjects taking the eradication drug from positive to negative HPS results.
Measured: 1 year
The affecting factors of gastric H. pylori eradication.
Questionnaire used in this study refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms, family history,side effects of medication, and compliance etc.Oral hygiene is assessed using the Simplified Oral Hygiene Index (OHI-S), which is the sum of the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S)..Dental caries is measured by the decay missing fill index (DMF),which refers to the sum of caries, lost and filled teeth.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between gastric H. pylori eradication failure and the factors.
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 posted13 Jul 2022
- Study start8 Jul 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Zhao, MD, Principal investigator, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455372
- Sponsor's protocol ID
- 2022187
- Acronym
- Hp
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors of Oral Helicobacter Pylori Infection and Oral Related Factors on Gastric Helicobacter Pylori Infection and Eradication Therapy Among the Outpatients of A Tertiary Hospital in Xi'an
- ClinicalTrials.gov ID
- NCT05455372
- Acronym / sponsor ID
- Hp / 2022187
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Oral hygiene, Dental caries, Risk factor, Saliva Test Cassette
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 13 Jul 2022 (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.
Helicobacter pylori (H. pylori) is closely related to the occurrence of gastric cancer and other diseases. The discovery and eradication of H. pylori is of great significance for the prevention and treatment of related diseases. Oral H. pylori may act as a "reservoir" to cause H. pylori to spread between populations and to cause individual gastric H. pylori infection and recurrence.Understanding the oral and gastric H. pylori infection and influencing factors of the population can provide scientific basis for the formulation of local H. pylori infection prevention strategies.Analyzing the influencing factors of H. pylori eradication in the population can improve the local H. pylori eradication rate and reduce the recurrence of H. pylori infection.Therefore, this study intends to analyze the influence of oral H. pylori infection and oral related factors on gastric H. pylori infection and eradication therapy in outpatients of a tertiary hospital in Xi'an.
Detailed description
Taking 300 dyspepsia patients who will undergo C13-urea breath test (C13-UBT) in the outpatient department of gastroenterology of the Second Affiliated Hospital of Xi'an Jiaotong University from July 2022 to March 2024 as the research subjects. A questionnaire survey on factors related to H. pylori infection will be conducted,which include basic information, eating habits, living environment, and oral care habits.From July 2022 to March 2024, Taking 300 patients who will be diagnosed with gastric H. pylori infection in the Gastroenterology Department of the Second Affiliated Hospital of Xi'an Jiaotong University and receive bismuth quadruple H. pylori eradication therapy as the research subjects.The bismuth quadruple regimen is specifically ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.The research subjects will be also required to complete a questionnaire survey on factors related to the eradication therapy of gastric H. pylori,the contents of the questionnaire include basic information, living habits, side effects of medication, and compliance.All the above populations will be given H. pylori Saliva Test Cassette (HPS) to detect whether H. pylori infection in the oral cavity, and the oral hygiene score (OHI) and the permanent tooth decay missing fill index (DMF) will be also evaluated and recorded.4-6 weeks after the end of treatment, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication, and the oral H. pylori infection will be re-detected by HPS.The patients with successful eradication therapy of gastric H. pylori will be followed up, and the recurrence of gastric H. pylori will be confirmed by 13C-UBT 1 year later.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oral H. pylori negative and gastric H. pylori negative group | No intervention | –These people are tested negative for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS). |
| oral H. pylori positive and gastric H. pylori negative group | No intervention | –These people are tested negative for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS). |
| oral H. pylori negative and gastric H. pylori positive group | Experimental | Drug: PPI quadruple therapyThese patients are tested positive for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS),they are given PPI quadruple therapy for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication.At the same time, Patients with successful eradication will be instructed to conduct 13C-UBT examination after 1year to confirm whether the recurrence of gastric H. pylori. |
| oral H. pylori positive and gastric H. pylori positive group | Experimental | Drug: PPI quadruple therapyThese patients are tested positive for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS),they are given PPI quadruple therapy for 14 days. After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to confirm the results of gastric H. pylori eradication, and the oral H. pylori infection will be re-detected by HPS.At the same time, Patients with successful eradication will be instructed to conduct 13C-UBT examination after 1year to confirm whether the recurrence of gastric H. pylori. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The first stage:Study the prevalence and risk factors of oral and gastric H. pylori infection 1. No obstacle to understanding the content of the questionnaire, and can answer the questions accurately, 2. Voluntarily participate in this research and sign the informed consent. The second stage:Study the status and influencing factors of eradication therapy of oral and gastric H. pylori
- >18 years old,
- Initial H. pylori eradication therapy,
- No obstacle to understanding the content of the questionnaire, and can answer the questions accurately,
- Agree to perform eradication treatment and receive telephone follow-up, and sign the informed consent.
Key exclusion criteria (6 listed)
- The first stage:Study the prevalence and risk factors of oral and gastric H. pylori infection
- History of taking proton pump inhibitors (PPI), H2 receptor blockers and bismuth agent within two weeks before enrollment,
- History of taking antibiotics and Chinese medicines with antibacterial effect within one month before enrollment,
- Complete or partial gastrectomy,
- Edentulous. The second stage:Study the status and influencing factors of eradication therapy of oral and gastric H. pylori
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 quadruple therapyPPI quadruple therapy refers to ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid. | Drug | oral H. pylori negative and gastric H. pylori positive group, oral H. pylori positive and gastric H. pylori positive group |
Primary outcome
Oral and gastric H. pylori infection rate
Time frame: 1 year
The gastric infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing 13-UBT,The oral infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing HPS.(On the 13-UBT,if the result DOB≥4. 0‰, it can be determined that the subject is gastric H. pylori positive; DOB <4. 0‰,the subject is gastric H. pylori negative.On the HPS,If the T line and C line appear, it is judged to be positive for oral H. pylori infection, but if the C line appears, it is judged to be negative for oral H. pylori infection. If the C line does not appear, it is an invalid test result and needs to be re-tested.)
The affecting factors of oral and gastric H. pylori infection.
Time frame: 1 year
Questionnaire used in this study refers to"National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Oral hygiene is assessed using the Simplified Oral Hygiene Index (OHI-S), which is the sum of the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S).Dental caries is measured by the decay missing fill index (DMF),which refers to the sum of caries, lost and filled teeth.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between oral and gastric H. pylori infection and the factors.
Oral and gastric H. pylori eradication rate
Time frame: 1 year
The gastric H. pylori positive patients receive PPI quadruple therapy,and after 4-6 weeks of completing eradication therapy, 13C-UBT and HPS are performed.The gastric H. pylori eradication rate is defined as the ratio of the number of subjects who become negative through 13C-UBT after taking the eradication drug to the number of all subjects who take the eradication drug.The oral H. pylori eradication rate is defined as the proportion of subjects taking the eradication drug from positive to negative HPS results.
The affecting factors of gastric H. pylori eradication.
Time frame: 1 year
Questionnaire used in this study refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms, family history,side effects of medication, and compliance etc.Oral hygiene is assessed using the Simplified Oral Hygiene Index (OHI-S), which is the sum of the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S)..Dental caries is measured by the decay missing fill index (DMF),which refers to the sum of caries, lost and filled teeth.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between gastric H. pylori eradication failure and the factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- 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.
Ping Zhao, MD principal investigator
Second Affiliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI quadruple therapy in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital of Xi'an Jiaotong 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 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Zhao, MD (13659287149, peggyzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral and gastric H. pylori infection rate (time frame: 1 year). The study lists 4 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 13 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.