Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

NCT05790512 | Completed

• 1 other identifier: KY20232027-C-1-A
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Keywords

Oral Helicobacter Pylori; Helicobacter Pylori Gastric

Outcome Measures

Primary Outcomes (1)

• Positive rate of oral Helicobacter pylori

  The oral Helicobacter pylori test is performed using the Helicobacter pylori test kit

  7 months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are from Xijing Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

Study Officials

• Yongquan Shi, PhD

  Xijing Hosipital of Digestive Disease

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: November 22, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

CN (1)