Comparison of the Effect of Helicobacter Pylori Eradication Before and After the 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: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Behavioral: Standardized training on Helicobacter pylori eradication treatment

Detailed Description

The researchers recruited gastroenterologists to participate in the study, and gastroenterologists recruited Helicobacter pylori-positive patients. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. After waiting for all patients admitted by gastroenterologists to be eradicated and re-examined, we will provide standardized Helicobacter pylori eradication training for gastroenterologist subjects. After the training, gastroenterologists recruit Helicobacter pylori-positive patients here. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. Compare the eradication rate, the incidence of adverse reactions, and the compliance of the patients before and after the training of the gastroenterologists.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 standardized Helicobacter pylori eradication training	1 year

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

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

Drug and device information, study documents

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