Clinical trial NCT05455372: Influence of Oral Hp Infection and Oral Related Factors on Gastric Hp Infection and Eradication Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Oral hygiene
Dental caries
Risk factor
Saliva Test Cassette
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

1. \>18 years old,
2. Initial H. pylori eradication therapy,
3. No obstacle to understanding the content of the questionnaire, and can answer the questions accurately,
4. Agree to perform eradication treatment and receive telephone follow-up, and sign the informed consent.

Exclusion Criteria:

The first stage:Study the prevalence and risk factors of oral and gastric H. pylori infection

1. History of taking proton pump inhibitors (PPI), H2 receptor blockers and bismuth agent within two weeks before enrollment,
2. History of taking antibiotics and Chinese medicines with antibacterial effect within one month before enrollment,
3. Complete or partial gastrectomy,
4. 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.

Primary outcomes:
measure: Oral and gastric H. pylori infection rate
timeFrame: 1 year
measure: The affecting factors of oral and gastric H. pylori infection.
timeFrame: 1 year
measure: Oral and gastric H. pylori eradication rate
timeFrame: 1 year
measure: The affecting factors of gastric H. pylori eradication.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of Xi'an Jiaotong university
state: Shaanxi
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Ping Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: