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

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PPI quadruple therapy
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Oral hygiene, Dental caries, Risk factor, Saliva Test Cassette

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • The second affiliated hospital of Xi'an Jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

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

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

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

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

Arm Description

These people are tested negative for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS).

These people are tested negative for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS).

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.

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.

Outcomes

Primary Outcome Measures

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.)
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2022
Last Updated
July 8, 2022
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05455372
Brief Title
Influence of Oral Hp Infection and Oral Related Factors on Gastric Hp Infection and Eradication Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Oral hygiene, Dental caries, Risk factor, Saliva Test Cassette

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral H. pylori negative and gastric H. pylori negative group
Arm Type
No Intervention
Arm Description
These people are tested negative for C13-urea breath test (C13-UBT) and negative for H. pylori Saliva Test Cassette (HPS).
Arm Title
oral H. pylori positive and gastric H. pylori negative group
Arm Type
No Intervention
Arm Description
These people are tested negative for C13-urea breath test (C13-UBT) and positive for H. pylori Saliva Test Cassette (HPS).
Arm Title
oral H. pylori negative and gastric H. pylori positive group
Arm Type
Experimental
Arm 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.
Arm Title
oral H. pylori positive and gastric H. pylori positive group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PPI quadruple therapy
Intervention Description
PPI quadruple therapy refers to ilaprazole 5mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid.
Primary Outcome Measure Information:
Title
Oral and gastric H. pylori infection rate
Description
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.)
Time Frame
1 year
Title
The affecting factors of oral and gastric H. pylori infection.
Description
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.
Time Frame
1 year
Title
Oral and gastric H. pylori eradication rate
Description
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.
Time Frame
1 year
Title
The affecting factors of gastric H. pylori eradication.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 >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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Zhao, MD
Phone
13659287149
Email
peggyzhao@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao She, MD
Phone
15709603775
Email
sheandxiao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Zhao, MD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affiliated hospital of Xi'an Jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Zhao, MD
Phone
13659287149
Email
peggyzhao@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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