Influence of Oral Hp Infection and Oral Related Factors on Gastric Hp Infection and Eradication Therapy

Xi'an Jiaotong University

Status: Enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: PPI quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05455372

2022187

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

5. Allergic to penicillin, clarithromycin, ilaprazole, colloidal bismuth tartrate, 2. Complete or partial gastrectomy, 3. Oral scaling within 6 months, 4. Edentulous.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

oral H. pylori negative and gastric H. pylori negative group

No Intervention group

Description:

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 group

Description:

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 group

Description:

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.

Treatment:

Drug: PPI quadruple therapy

oral H. pylori positive and gastric H. pylori positive group

Experimental group

Description:

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.

Treatment:

Drug: PPI quadruple therapy