Association of Oral Helicobacter Pylori Infection With Ga... | NCT05790512

Studies
Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

NCT05790512

Sponsor

Xijing Hospital of Digestive Diseases

Status

Completed

Last Update Posted

Aug 4, 2023Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Helicobacter Pylori

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2022Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2023

Last Update Posted Date

Aug 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive DiseasesPrincipal Investigator

Lead Sponsor

Xijing Hospital of Digestive DiseasesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to investigate the association between oral Helicobacter pylori infection and gastric Helicobacter pylori infection. Patients who were tested for gastric Helicobacter pylori were tested for oral Helicobacter pylori at the same time, and were divided into four groups according to the test results to compare the positive rate of oral Helicobacter pylori.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Both gastric and oral Helicobacter pylori are negative
Negative for Helicobacter pylori for gastric and positive for Helicobacter pylori for oral cavity
Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
Both gastric and oral Helicobacter pylori are positive

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive rate of oral Helicobacter pylori	The oral Helicobacter pylori test is performed using the Helicobacter pylori test kit	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18~70 ,both gender.
Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
Have not received dental care or systemic periodontal basic treatment in the past 1 year.

Exclusion Criteria:

There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
Those with severe oral diseases and malignant tumors of the mouth.
Previously had upper gastrointestinal surgery.
Refusal to sign informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients are from Xijing Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yongquan Shi, PhD	Xijing Hosipital of Digestive Disease	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hosipital of Digestive Disease		Xi'an	Shaanxi	710032	China