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

NCT05790525 | Completed Phase 4

• 1 other identifier: KY20232027-C-1-B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Keywords

Oral Helicobacter pylori; Helicobacter pylori gastric; Eradication rate of Helicobacter pylori in the stomach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral Helicobacter pylori conversion rate

  28 days after treatment

Study Arms (2)

Both gastric and oral Helicobacter pylori are positive

OTHER

Drug: Standard bismuth quadruple

Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity

OTHER

Drug: Standard bismuth quadruple

Interventions

Standard bismuth quadruple DRUG

Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

Both gastric and oral Helicobacter pylori are positive; Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18\~70 ,both gender.
• Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
• Have not received dental care or systemic periodontal basic treatment in the past 1 year.

You may not qualify if:

• Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
• There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
• 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).
• Those with severe oral diseases and malignant tumors of the mouth.
• Women planning pregnancy, pregnancy and breastfeeding.
• Previously had upper gastrointestinal surgery.
• Those who do not take their medication on time.
• Refusal to sign informed consent.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Study Officials

• Yongquan Shi, PhD

  Xijing Hosipital of Digestive Disease

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: November 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

CN (1)