Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

Helicobacter Pylori Clinical Trial

Official title:

Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790525
• Other study ID #: KY20232027-C-1-B
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Helicobacter Pylori
• Infections

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