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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05790512
Other study ID # KY20232027-C-1-A
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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