Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists

Comparison of the Effect of Helicobacter Pylori Eradication Before and After the Training of Gastroenterologists on Standardized Helicobacter Pylori Eradication Therapy

The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Behavioral: Standardized training on Helicobacter pylori eradication treatment

Detailed Description

The researchers recruited no less than 20 gastroenterologists to participate in the study, and gastroenterologists recruited 25 patients who were over 18 years of age and were positive for Helicobacter pylori for the first time. In this process, the patient population is not restricted, and the eradication program is not restricted. Gastroenterologists followed up their diagnosis and treatment. Researchers track and record patients' medications and adverse reactions during medication via phone or WeChat to assess patient compliance. Record the eradication rate. The researchers will provide standardized Helicobacter pylori eradication training for the Department of Gastroenterology after all patients treated by gastroenterologists have been eradicated and reviewed. After the training, the gastroenterologist recruited 25 patients who were over 18 years old and were newly treated with Helicobacter pylori positive. In this process, the patient population is not restricted, and the eradication program is not restricted. Gastroenterologists followed up their diagnosis and treatment. Researchers track and record patients' medications and adverse reactions during medication via phone or WeChat to assess patient compliance. Record the eradication rate. Compare the eradication rate, adverse reaction rate and compliance of patients before and after the training of gastroenterologists.

• Study Type: Interventional
• Enrollment (Actual): 1025
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 257000
      • Xiuli Zuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1.Physician specialized in gastroenterology.
• 2.Diagnosis and treatment conditions for H. pylori exist in the hospital where the gastroenterology doctor is located.

(C13 urea breath test, C14 urea breath test, rapid urease test, stool H. pylori antigen test, histopathological test, H. pylori culture, any of the above)

Exclusion Criteria:

• 1.Those who are unable or unwilling to provide informed consent.
• 2.Patients with H. pylori have never been diagnosed and treated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After receiving standardized training on Helicobacter pylori eradication; After the gastroenterologists receive standardized training to eradicate Helicobacter pylori, they recruit Helicobacter pylori-positive patients for treatment.	Behavioral: Standardized training on Helicobacter pylori eradication treatment; Standardized training on Helicobacter pylori eradication treatment
No Intervention: Before receiving standardized training on Helicobacter pylori eradication; Gastroenterologists recruited patients with Helicobacter pylori positive for treatment before receiving standardized training on Helicobacter pylori eradication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	The eradication rate of before and after the gastroenterologists receiving	1 year

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, MD,PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Standardized training on Helicobacter pylori eradication; Gastroenterologist
• Other Study ID Numbers: 2021SDU-QILU-G004-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No