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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05790525
Other study ID # KY20232027-C-1-B
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 22, 2022
Est. completion date November 2023

Study information

Verified date August 2023
Source Xijing Hospital of Digestive Diseases
Contact Jiaojiao Cao
Phone : +86-15029258646
Email 2119811879@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 2023
Est. primary completion date September 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. Those who have contraindications to the drugs used in this institute or are allergic to the drugs used. 2. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases. 3. 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). 4. Those with severe oral diseases and malignant tumors of the mouth. 5. Women planning pregnancy, pregnancy and breastfeeding. 6. Previously had upper gastrointestinal surgery. 7. Those who do not take their medication on time. 8. Refusal to sign informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Standard bismuth quadruple
Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

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 Eradication rate of Helicobacter pylori in the stomach The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative 28 days after treatment
Secondary Oral Helicobacter pylori conversion rate Oral Helicobacter pylori conversion rate 28 days after treatment 28 days after treatment
See also
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