Helicobacter Pylori InfectionNCT04850209
The Impact of WeChat Group Patient Education on the Eradication Rate of Helicobacter Pylori
A study testing oral and written education and Wechat group in people with Helicobacter Pylori Infection and Helicobacter Pylori Eradication, run by Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori Eradication, Patient Education
- What is being tested?
- oral and written education and Wechat group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2021to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 75 years old;
- H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.
Who cannot join
- previous therapy for H. pylori;
- with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study;
- history of gastric surgery,
- pregnancy or lactation;
- the use of PPI or antibiotics during the 4 weeks prior to enrolment;
- previous history of allergic reactions to any of the medications used in this protocol;
- unable to use smartphone and wechat
- unwilling or incapable to provide informed consents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Interactive Patient Education Based on WeChat Group on the Eradication Rate of Helicobacter Pylori
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.
Read the detailed 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.
- Being tested
- oral and written education, Wechat group
- Keywords
- helicobacter pylori, eradication, patient education, Wechat group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral and written educationOther
oral and written education
Wechat groupOther
Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg , amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education Receives: Other: oral and written education |
| Wechat group | Experimental | Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg ,amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education. And patients will be invited into a Wechat group to obtain interactive education through question and answer,which is provided by medical professionals. Receives: Other: oral and written education; Other: Wechat group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start23 Jul 2021
- Primary completion10 Aug 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two randomized parallel groups in this study, control group and Wechat group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850209
- Sponsor's protocol ID
- 2021SDU-QILU-067
- Status last verified
- Jan 2023
- First submitted
- 7 Apr 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin B, Zhang W, Zhang J, Lin M, Liu J, Han Z, Ding Y, Kong Q, Duan M, Li Y, Zuo X, Li Y. Use of WeChat-based patient-doctor interaction improves patient experience of Helicobacter pylori treatment: a randomized controlled trial. Front Digit Health. 2026 May 29;8:1744252. doi: 10.3389/fdgth.2026.1744252. eCollection 2026.
PubMed 42294054
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Interactive Patient Education Based on WeChat Group on the Eradication Rate of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT04850209
- Acronym / sponsor ID
- 2021SDU-QILU-067
- Keywords
- helicobacter pylori, eradication, patient education, Wechat group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two randomized parallel groups in this study, control group and Wechat group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: oral and written educationPatients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg , amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education |
| Wechat group | Experimental | Other: oral and written education, Other: Wechat groupPatients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg ,amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education. And patients will be invited into a Wechat group to obtain interactive education through question and answer,which is provided by medical professionals. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 18 and 75 years old;
- H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.
Key exclusion criteria (8 listed)
- previous therapy for H. pylori;
- with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study;
- history of gastric surgery,
- pregnancy or lactation;
- the use of PPI or antibiotics during the 4 weeks prior to enrolment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral and written educationoral and written education | Other | Control group, Wechat group |
| Wechat groupWechat group: oral and written education plus Wechat group based interactive education provided by medical professional | Other | Wechat group |
Primary outcome
eradication rate in each group
Time frame: 2 months
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.
1 secondary outcome
prevalence of adverse events
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 42294054Lin B, Zhang W, Zhang J, Lin M, Liu J, Han Z, Ding Y, Kong Q, Duan M, Li Y, Zuo X, Li Y. Use of WeChat-based patient-doctor interaction improves patient experience of Helicobacter pylori treatment: a randomized controlled trial. Front Digit Health. 2026 May 29;8:1744252. doi: 10.3389/fdgth.2026.1744252. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral and written education and Wechat group in people with Helicobacter Pylori Infection and Helicobacter Pylori Eradication, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication rate in each group (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.