Helicobacter Pylori InfectionPhase 4NCT03616405
Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection
A Phase 4 study testing rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days) in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Apr 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 with persistent H. pylori infection.
- Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.
Who cannot join
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
- History of allergy to any of the drugs used in the study.
- Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
- Currently pregnant or lactating.
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- Severe neurologic or psychiatric disorders.
- Alcohol abuse or drug addiction.
- Patients with compliance lower than 90% in any previous treatment are not included.
- Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Trial locations and contacts
1 site in 1 country.
Xiuli Zuo, MD,PhD contact
About this study
Official title: Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: a Pilot Study
The purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Read the detailed description
Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
Traditional sequential therapy failed to achieve an ideal eradication rates (over>95%) as a third line treatment in the region with high antibiotic resistance. The investigator's study aims to evaluate the efficacy 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)
- Keywords
- Sequential Therapy, Rescue Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)Drug
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 14-day modified sequential therapy | Experimental | All the participants will go through a gastroscopy. Biopsy specimens will be taken for histologic assessment and rapid urease test. Two additional biopsy samples will be obtained from the antrum and body for bacterial culture and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment.
Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.
Drugs: 1. rabeprazole 10mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the firs 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days. Receives: Drug: rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Measured: 6 months
Secondary outcomes (3)
The rate of adverse events happening
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Measured: 6 months
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Dyspepsia symptoms will also be measured using a 8-point Likert scale
Measured: 6 months
The rate of good compliance
Patients taken over 90% of drugs are considered to have a good compliance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Apr 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616405
- Sponsor's protocol ID
- 2018SDU-QILU-G001
- Status last verified
- Mar 2019
- First submitted
- 31 Jul 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a 14-day Modified Sequential Therapy for Refractory Helicobacter Pylori Infection: a Pilot Study
- ClinicalTrials.gov ID
- NCT03616405
- Acronym / sponsor ID
- 2018SDU-QILU-G001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Sequential Therapy, Rescue Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 6 Aug 2018 (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 purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Detailed description
Half of the world's population is infected with Helicobacter pylori. Strong evidence supports that H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.
Traditional sequential therapy failed to achieve an ideal eradication rates (over>95%) as a third line treatment in the region with high antibiotic resistance. The investigator's study aims to evaluate the efficacy 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14-day modified sequential therapy | Experimental | Drug: rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)All the participants will go through a gastroscopy. Biopsy specimens will be taken for histologic assessment and rapid urease test. Two additional biopsy samples will be obtained from the antrum and body for bacterial culture and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication irrespective of antimicrobial susceptibility test results. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days. Drugs: 1. rabeprazole 10mg bid for 14 days, 2. amoxicillin 1000mg bid for 14 days, 3. tetracycline 500mg qid for 14 days, 4. furazolidone 100mg tid for the firs 7 days, 5. colloidal bismuth pectin 200mg bid for the second 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 with persistent H. pylori infection.
- Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.
Key exclusion criteria (10 listed)
- Patients unable or unwilling to receive gastroscopy.
- Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
- Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
- History of allergy to any of the drugs used in the study.
- Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
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 |
|---|---|---|
| rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days. | Drug | 14-day modified sequential therapy |
Primary outcome
Eradication rates
Time frame: 6 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
3 secondary outcomes
The rate of adverse events happening
Time frame: 6 months
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.
Time frame: 6 months
The rate of good compliance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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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.
Xiuli Zuo, MD,PhD contact
Xiuli Zuo, 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 rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days) in people with Helicobacter Pylori Infection, 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 10 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 8 Mar 2019. 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 Xiuli Zuo, MD,PhD (15588818685, zuoxiuli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rates (time frame: 6 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 8 Mar 2019.