Clinical Trials Directory

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UnknownNCT05455372

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
600 (estimated)
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPPI quadruple therapyPPI quadruple therapy refers to ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid.

Timeline

Start date
2022-07-08
Primary completion
2023-09-30
Completion
2024-03-31
First posted
2022-07-13
Last updated
2022-07-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05455372. Inclusion in this directory is not an endorsement.