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

• Sponsor: Xijing Hospital of Digestive Diseases (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05790525
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Standard bismuth quadruple	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
• Actual Study Start Date: Nov 22, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Both gastric and oral Helicobacter pylori are positive	Drug: Standard bismuth quadruple; Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines
Other: Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity	Drug: Standard bismuth quadruple; Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines

Outcome Measures

Primary Outcome Measures

1. 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

1. Oral Helicobacter pylori conversion rate [28 days after treatment]

   Oral Helicobacter pylori conversion rate 28 days after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Xijing Hospital of Digestive Diseases

Investigators

• Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
• ClinicalTrials.gov Identifier: NCT05790525
• Other Study ID Numbers: KY20232027-C-1-B
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases: Oral Helicobacter pylori; Helicobacter pylori gastric; Eradication rate of Helicobacter pylori in the stomach
• Additional relevant MeSH terms: Infections; Bismuth

Study Results

No Results Posted as of Mar 30, 2023