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

Phase 4

Recruiting

• Conditions: Helicobacter Pylori
• Interventions: Drug: Standard bismuth quadruple

• Registration Number: NCT05790525
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04
• Primary Completion: 2023-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Both gastric and oral Helicobacter pylori are positive	Standard bismuth quadruple	-
Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity	Standard bismuth quadruple	-

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori in the stomach	28 days after treatment	The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative

Secondary Outcome Measures

Name	Time	Method
Oral Helicobacter pylori conversion rate	28 days after treatment	Oral Helicobacter pylori conversion rate 28 days after treatment

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China