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

Primary Purpose

Helicobacter Pylori

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Standard bismuth quadruple
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori focused on measuring Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Xijing Hosipital of Digestive DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Both gastric and oral Helicobacter pylori are positive

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oral Helicobacter pylori conversion rate
Oral Helicobacter pylori conversion rate 28 days after treatment

Full Information

First Posted
March 17, 2023
Last Updated
August 3, 2023
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05790525
Brief Title
Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
Official Title
Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori
Keywords
Oral Helicobacter pylori, Helicobacter pylori gastric, Eradication rate of Helicobacter pylori in the stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Both gastric and oral Helicobacter pylori are positive
Arm Type
Other
Arm Title
Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Standard bismuth quadruple
Intervention Description
Use the standard bismuth quadruple regimen recommended by the latest Chinese guidelines
Primary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori in the stomach
Description
The primary end point of this study is to compare the rate of gastric Helicobacter pylori eradication in oral Helicobacter pylori positive and negative
Time Frame
28 days after treatment
Secondary Outcome Measure Information:
Title
Oral Helicobacter pylori conversion rate
Description
Oral Helicobacter pylori conversion rate 28 days after treatment
Time Frame
28 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaojiao Cao
Phone
: +86-15029258646
Email
2119811879@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Shi, PhD
Phone
86-029-84771515
Email
shiyquan@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, PhD
Organizational Affiliation
Xijing Hosipital of Digestive Disease
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, PhD
Phone
86-029-84771515
Email
shiyquan@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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