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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850209
Other study ID # 2021SDU-QILU-067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2021
Est. completion date September 10, 2022

Study information

Verified date January 2023
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, effects of oral and written education, WeChat education plus oral and written education on Helicobacter pylori eradication will be compared in a randomized way.


Description:

There are two randomized parallel groups in this study, control group and Wechat group.All of the patients will be treated with Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate. In control group,the patients will be educated by oral and written way about the regimen. In Wechat group, the patients will be educated by Wechat oral and written way. Then, the eradication rates, compliance, adverse events, patients' satisfaction and experience will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 438
Est. completion date September 10, 2022
Est. primary completion date August 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. aged between 18 and 75 years old; 2. H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology. Exclusion Criteria: 1. previous therapy for H. pylori; 2. with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study; 3. history of gastric surgery, 4. pregnancy or lactation; 5. the use of PPI or antibiotics during the 4 weeks prior to enrolment; 6. previous history of allergic reactions to any of the medications used in this protocol; 7. unable to use smartphone and wechat 8. unwilling or incapable to provide informed consents.

Study Design


Intervention

Other:
oral and written education
oral and written education
Wechat group
Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional

Locations

Country Name City State
China Qilu hosipital Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other compliance of patients in the two groups compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken. 14 days
Primary eradication rate in each group Six weeks after completion of treatment,number of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. 2 months
Secondary prevalence of adverse events At the follow-up,adverse events complained by patients will be recorded by an independent researcher,meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events. 14 days
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