Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

• Study Contact: Name: Jiaojiao Cao; Phone Number: : +86-15029258646; Email: 2119811879@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hosipital of Digestive Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients are from Xijing Hospital.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
2. 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).
3. Those with severe oral diseases and malignant tumors of the mouth.
4. Previously had upper gastrointestinal surgery.
5. Refusal to sign informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Oral Helicobacter Pylori; Helicobacter Pylori Gastric
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: KY20232027-C-1-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No