NCT05455372

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

July 8, 2022

Last Update Submit

July 8, 2022

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriOral hygieneDental cariesRisk factorSaliva Test Cassette

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

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

NO INTERVENTION

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

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

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.

Drug: PPI quadruple therapy

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

EXPERIMENTAL

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.

Drug: PPI quadruple therapy

Interventions

PPI quadruple therapyDRUG

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

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Xi'an Jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ping Zhao, MD

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Zhao, MD

CONTACT

13659287149peggyzhao@163.com

Xiao She, MD

CONTACT

15709603775sheandxiao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 13, 2022

Study Start

July 8, 2022

Primary Completion

September 30, 2023

Study Completion

March 31, 2024

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)