Comparison of the Effect of Helicobacter Pylori Eradicati... | NCT04984382

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

NCT04984382

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Nov 16, 2021Actual

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Helicobacter Pylori Infection

Interventions

Standardized training on Helicobacter pylori eradication treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2021Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Jul 27, 2021

First Submission Date that Met QC Criteria

Jul 27, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2021

Last Update Posted Date

Nov 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiuli Zuo, doctoral supervisor of Qilu Hospital gastroenterology department, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
After receiving standardized training on Helicobacter pylori eradication	Experimental	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
Before receiving standardized training on Helicobacter pylori eradication	No Intervention	Gastroenterologists recruited patients with Helicobacter pylori positive for treatment before receiving standardized training on Helicobacter pylori eradication.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standardized training on Helicobacter pylori eradication treatment	Behavioral	Standardized training on Helicobacter pylori eradication treatment	After receiving standardized training on Helicobacter pylori eradication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eradication rate	The eradication rate of before and after the gastroenterologists receiving standardized Helicobacter pylori eradication training	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiuli Zuo, MD, PhD	Contact	86 15588818685	0531-88369277	zuoxiuli@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Xiuli Zuo, MD,PhD	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiuli Zuo	Recruiting	Jinan	Shandong	257000	China