NCT07335406

Brief Summary

Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations. Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Nov 2035

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2035

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2035

Last Updated

April 2, 2026

Status Verified

January 1, 2026

Enrollment Period

9.8 years

First QC Date

January 5, 2026

Last Update Submit

March 27, 2026

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    at least 6 weeks after treatment completion

Secondary Outcomes (1)

  • Adverse events

    immediately after treatment completion

Interventions

Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.OTHER

Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstance, not involve any intervention procedure.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

(1) patients aged 18-80 years, regardless of gender; (2) willing to receive H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.

You may qualify if:

  • patients aged 18-80 years, regardless of gender;
  • willing to receive H. pylori eradication therapy;
  • diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.

You may not qualify if:

  • patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
  • patients with severe underlying conditions such as hepatic insufficiency, renal insufficiency, or malignant tumours;
  • pregnant or breastfeeding women;
  • individuals who refuse to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Central Study Contacts

Yueyue Li

CONTACT

18560089751lyynqj@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

November 1, 2035

Study Completion (Estimated)

November 30, 2035

Last Updated

April 2, 2026

Record last verified: 2026-01

Locations

CN(2)