Helicobacter Pylori Eradication RatePhase 4NCT02833623
Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication
A Phase 4 study testing Short-message-based Re-education and conventional education in people with Helicobacter Pylori Eradication Rate, run by Shandong University at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Eradication Rate
- What is being tested?
- Short-message-based Re-education and conventional education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jan 2017
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- outpatients aged 18-70 years
- confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
- an intention of H. pylori eradication treatment and have written inform consent
- ability to read short messages on the mobile phone
Who cannot join
- advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
- allergy to any of the drugs used in this study
- previous Helicobacter Pylori eradication treatment
- pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
- taking antibiotics or PPIs or bismuth salts within four weeks
- previous gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
yanqing li, MD. PhD., 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
Yanqing Li, MD. PhD.
About this study
Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.
- Conditions
- Helicobacter Pylori Eradication Rate
- Being tested
- Short-message-based Re-education, conventional education
- Keywords
- Helicobacter Pylori eradication rate, Efficacy of Short-message-based Re-education (SMRE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-message-based Re-educationBehavioural
conventional educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Short-message-based Re-education group | Experimental | Patients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy.
Both the content of the oral and written education and the short message re-education are same. Receives: Behavioral: Short-message-based Re-education |
| conventional education group | Active comparator | Patients only receive oral and written education before H. pylori eradication therapy. Receives: Behavioral: conventional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of H. pylori eradication rate between two groups
Measured: 8 months
Secondary outcomes (1)
Rate of non-compliance with instructions between 2 groups
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Eradication RateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833623
- Sponsor's protocol ID
- 2016SDU-QILU-07
- Status last verified
- Oct 2016
- First submitted
- 7 Jul 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT02833623
- Acronym / sponsor ID
- 2016SDU-QILU-07
- Conditions
- Helicobacter Pylori Eradication Rate
- Keywords
- Helicobacter Pylori eradication rate, Efficacy of Short-message-based Re-education (SMRE)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- 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.
Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-message-based Re-education group | Experimental | Behavioral: Short-message-based Re-educationPatients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy. Both the content of the oral and written education and the short message re-education are same. |
| conventional education group | Active comparator | Behavioral: conventional educationPatients only receive oral and written education before H. pylori eradication therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- outpatients aged 18-70 years
- confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
- an intention of H. pylori eradication treatment and have written inform consent
- ability to read short messages on the mobile phone
Key exclusion criteria (6 listed)
- advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
- allergy to any of the drugs used in this study
- previous Helicobacter Pylori eradication treatment
- pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
- taking antibiotics or PPIs or bismuth salts within four weeks
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 |
|---|---|---|
| Short-message-based Re-education | Behavioural | Short-message-based Re-education group |
| conventional education | Behavioural | conventional education group |
Primary outcome
The difference of H. pylori eradication rate between two groups
Time frame: 8 months
1 secondary outcome
Rate of non-compliance with instructions between 2 groups
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
Related trials for Helicobacter Pylori Eradication Rate
RecruitingPhase 4
CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
H. Pylori Gastrointestinal Disease, H.Pylori Infection
RecruitingPhase 3
Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection
Helicobacter Pylori Eradication Rate
Enrolling by invitation
to Assess the Eradication Rate of 14-day Bismuth/Amoxicillin/PCAB Triple Therapy for the Treatment of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
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.
Yanqing Li, MD,PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Short-message-based Re-education and conventional education in people with Helicobacter Pylori Eradication Rate, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD,PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of H. pylori eradication rate between two groups (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.