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

Helicobacter Pylori Infection Clinical Trial

— Hp  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455372
• Other study ID #: 2022187
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Ping Zhao, MD
• Phone: 13659287149
• Email: peggyzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• PPI quadruple therapy
PPI quadruple therapy refers to ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid.

Locations

Country	Name	City	State
China	The second affiliated hospital of Xi'an Jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year