Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

Helicobacter Pylori Clinical Trial

Official title:

Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790512
• Other study ID #: KY20232027-C-1-A
• Status: Completed
• Start date: November 22, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori
• Infections

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive rate of oral Helicobacter pylori	The oral Helicobacter pylori test is performed using the Helicobacter pylori test kit	7 months