Helicobacter Pylori InfectionNCT05549115
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
A study testing clarithromycin-sensitive(first-line), clarithromycin-resistant(first-line) and empirical therapy group first-line in people with Helicobacter Pylori Infection, run by Liaocheng People's Hospital at 1 site in China.
Trial summary
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- clarithromycin-sensitive(first-line), clarithromycin-resistant(first-line) and empirical therapy group first-line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
- Patients were naïve to H. pylori treatment.
Who cannot join
- Allergy to any drug administered.
- Pregnancy and lactation.
- Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
- Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liaocheng people's hospital
Liaocheng, Shandong, 252000
Jingrun Zhao, Dr, +86-635-8276373, zhjrun77@163.com
About this study
Official title: Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
Read the detailed description
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- clarithromycin-sensitive(first-line), clarithromycin-resistant(first-line), empirical therapy group first-line, levofloxacin-sensitive(rescue treatment), levofloxacin-resistant(rescue treatment)
- Keywords
- Helicobacter pylori, Drug Resistance, Microbial, Microbial Sensitivity Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin-sensitive(first-line)Drug
Also called clarithromycin triple therapy
esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
clarithromycin-resistant(first-line)Drug
Also called High-dose PPI-amoxicillin dual therapy
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
empirical therapy group first-lineDrug
Also called Bismuth-containing quadruple therapy
esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days
levofloxacin-sensitive(rescue treatment)Drug
Also called levofloxacin quadruple regimen
esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
levofloxacin-resistant(rescue treatment)Drug
Also called furazolidone quadruple regimen
esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days
empirical therapy group rescue treatmentDrug
Also called High-dose PPI-amoxicillin dual therapy
esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin-sensitive(first-line) | Experimental | If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days Receives: Drug: clarithromycin-sensitive(first-line) |
| clarithromycin-resistant(first-line) | Experimental | If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days. Receives: Drug: clarithromycin-resistant(first-line) |
| empirical therapy group first-line | Active comparator | The empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days. Receives: Drug: empirical therapy group first-line |
| levofloxacin-sensitive(rescue treatment) | Experimental | If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. Receives: Drug: levofloxacin-sensitive(rescue treatment) |
| levofloxacin-resistant(rescue treatment) | Experimental | If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. Receives: Drug: levofloxacin-resistant(rescue treatment) |
| empirical therapy group rescue treatment | Active comparator | If BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days. Receives: Drug: empirical therapy group rescue treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first-line H. pylori eradication rate
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
Measured: 4-8 weeks after the end of treatment.
Secondary outcomes (4)
the rescue H. pylori eradication rate
The second line eradication rate between SGT and ET group.
Measured: 4-8 weeks after the second treatment
the overall H.pylori eradication rate
the total H.pylori eradication rate (first-line and second-line)between SGT and ET group.
Measured: 4-8 weeks after the second treatment
high-dose dual therapy eradication rate
compare H. pylori eradication rate between clarithromycin resistance group and empirical BQT failure group.
Measured: 4-8 weeks after the second treatment
Adverse events and compliance
3 days after the completion of therapy according to a data collection form
Measured: 3 days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Sep 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing run Zhao, Dr, Study chair, Liaocheng People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549115
- Sponsor's protocol ID
- CS-HP001
- Status last verified
- Dec 2022
- First submitted
- 18 Sep 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu K, Zou X, Lang C, Zang L, Yang X, Sang W, Wang J, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-Guided Versus Empirical Therapy for Helicobacter pylori Infection in a High Resistance Setting: A Randomised Controlled Trial. Microbiologyopen. 2026 Jun;15(3):e70313. doi: 10.1002/mbo3.70313.
PubMed 42144812Lu K, Lang C, Zou X, Zang L, Sang W, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial. Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z.
PubMed 37337241
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility-Guided Sequential Therapy Versus Empirical Therapy for Helicobacter Pylori Infection: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05549115
- Acronym / sponsor ID
- CS-HP001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Drug Resistance, Microbial, Microbial Sensitivity Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Sep 2022 (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.
The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.
Detailed description
This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| clarithromycin-sensitive(first-line) | Experimental | Drug: clarithromycin-sensitive(first-line)If H. pylori is sensitive to clarithromycin, we will administer clarithromycin triple therapy-esomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily)-for 14 days |
| clarithromycin-resistant(first-line) | Experimental | Drug: clarithromycin-resistant(first-line)If H. pylori is clarithromycin resistance, we selected the High-dose dual therapy (HDDT) regimen as first-line treatment. HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used for 14 days. |
| empirical therapy group first-line | Active comparator | Drug: empirical therapy group first-lineThe empirical therapy group will receive Bismuth-containing quadruple therapy(BQT) as first-line treatment, The BQT regime is comprising of esomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days. |
| levofloxacin-sensitive(rescue treatment) | Experimental | Drug: levofloxacin-sensitive(rescue treatment)If H. pylori was levofloxacin-sensitive, we will use the levofloxacin quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. |
| levofloxacin-resistant(rescue treatment) | Experimental | Drug: levofloxacin-resistant(rescue treatment)If H. pylori was levofloxacin-resistant, we will use furazolidone quadruple regimen as rescue treatment-esomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily)-for 14 days. |
| empirical therapy group rescue treatment | Active comparator | Drug: empirical therapy group rescue treatmentIf BQT fails, HDDT-esomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily)-will be used as a rescue treatment for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
- Patients were naïve to H. pylori treatment.
Key exclusion criteria (4 listed)
- Allergy to any drug administered.
- Pregnancy and lactation.
- Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
- Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.
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 |
|---|---|---|
| clarithromycin-sensitive(first-line)Also: clarithromycin triple therapyesomeprazole (20 mg, twice daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days | Drug | clarithromycin-sensitive(first-line) |
| clarithromycin-resistant(first-line)Also: High-dose PPI-amoxicillin dual therapyesomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days | Drug | clarithromycin-resistant(first-line) |
| empirical therapy group first-lineAlso: Bismuth-containing quadruple therapyesomeprazole (20 mg, twice daily), colloidal bismuth pectin (150 mg, four times daily), clarithromycin (500 mg, twice daily), and amoxicillin (1.0 g, twice daily) for 14 days | Drug | empirical therapy group first-line |
| levofloxacin-sensitive(rescue treatment)Also: levofloxacin quadruple regimenesomeprazole (20 mg, twice daily), levofloxacin (500 mg, once daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days | Drug | levofloxacin-sensitive(rescue treatment) |
| levofloxacin-resistant(rescue treatment)Also: furazolidone quadruple regimenesomeprazole (20 mg, twice daily), furazolidone (100 mg, twice daily), amoxicillin (1.0 g, twice daily), and colloidal bismuth pectin (150 mg, four times daily) for 14 days | Drug | levofloxacin-resistant(rescue treatment) |
| empirical therapy group rescue treatmentAlso: High-dose PPI-amoxicillin dual therapyesomeprazole (20 mg, four times daily) and amoxicillin (750 mg, four times daily) for 14 days | Drug | empirical therapy group rescue treatment |
Primary outcome
the first-line H. pylori eradication rate
Time frame: 4-8 weeks after the end of treatment.
the proportion of participants with successful H. pylori eradication, as determined by 13C-Urea breath test(UBT), at least 4 weeks after the end of the first-line treatment period between Susceptibility-guided therapy(SGT) and empirical therapy(ET) group.
4 secondary outcomes
the rescue H. pylori eradication rate
Time frame: 4-8 weeks after the second treatment
the overall H.pylori eradication rate
Time frame: 4-8 weeks after the second treatment
high-dose dual therapy eradication rate
Time frame: 4-8 weeks after the second treatment
Adverse events and compliance
Time frame: 3 days after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 42144812Lu K, Zou X, Lang C, Zang L, Yang X, Sang W, Wang J, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-Guided Versus Empirical Therapy for Helicobacter pylori Infection in a High Resistance Setting: A Randomised Controlled Trial. Microbiologyopen. 2026 Jun;15(3):e70313. doi: 10.1002/mbo3.70313.
- Derived from this study: PubMed 37337241Lu K, Lang C, Zou X, Zang L, Sang W, Feng Q, Mu Y, Liu L, Xu C, Zhao J. Susceptibility-guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial. Trials. 2023 Jun 19;24(1):413. doi: 10.1186/s13063-023-07457-z.
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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.
Jing run Zhao, Dr study chair
Liaocheng People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clarithromycin-sensitive(first-line), clarithromycin-resistant(first-line) and empirical therapy group first-line in people with Helicobacter Pylori Infection, run by Liaocheng People's Hospital 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 4 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 12 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing run Zhao, Dr (+86-635-8276373, zhjrun77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first-line H. pylori eradication rate (time frame: 4-8 weeks after the end of treatment.). 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 NCT05549115, which also lists 2 linked publications.
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 12 Dec 2023.