Helicobacter Pylori EradicationNCT05870397
Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective Randomized Trial
A study testing HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times in people with Helicobacter Pylori Eradication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2023to 21 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no history of helicobacter pylori treatment
- the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.
Who cannot join
- used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion.
- had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction.
- had a history of esophagectomy or gastrectomy.
- had an allergy to any study drug.
- had severe comorbidities or physical or mental diseases.
- were pregnant or breastfeeding.
- had a history of alcohol abuse or drug addiction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
Hangzhou, Zhejiang, 310000
Yuehua Han, MD, +8613858126927, 13858126927@163.com
About this study
Official title: Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.
Read the detailed description
The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different timesDiagnostic test
Carbon 13 breath tests are generally performed 4-6 weeks after eradication therapy. The control group will perform breath urea test at 4-6 weeks after treatment. The experimental groups will perform the same test at different times after the same treatment, 6-8weeks and 8-10 weeks, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Recheck time is at 4 to 6 weeks after the eradication therapy | Placebo comparator | All cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 4 to 6 weeks( as guildeline suggested) after the treatment. Receives: Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times |
| Recheck time is at 6 to 8 weeks after eradication therapy | Active comparator | All cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 6 to8 weeks after the treatment. Receives: Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times |
| Recheck time is at 8 to 10 weeks after eradication therapy | Active comparator | All cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 8 to 10 weeks after the treatment. Receives: Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times |
What is being measured
The primary outcome is the main question the study is designed to answer.
the eradication rate in each group (ITT analysis)
According to the breath urea test, calculation the eradication rate in the three groups. ITT analysis, the number of negative breath test cases after treatment divided by the number of cases enrolled in eradication therapy.
Measured: up to 4 months after eradication therapy
the eradication rate in each group (PP analysis)
According to the breath urea test, calculation the eradication rate in the three groups. PP analysis, the number of negative breath test cases after treatment divided by the number of cases finished the eradication therapy
Measured: up to 4 months after eradication therapy
Secondary outcomes (1)
follow up of cut off cases
If the result of breath urea test is betwwen 2 to 6, it will be defined as cut off value. These cases will be collected and take further tests to make sure the real situation of helicobacter pylori infection.
Measured: up to 4 months after eradication therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start21 Apr 2023
- Primary completion21 Apr 2024 (estimated)
- Study completion21 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianting Cai, MD, Study chair, 2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870397
- Sponsor's protocol ID
- 2023-0184
- Status last verified
- Apr 2023
- First submitted
- 4 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05870397
- Acronym / sponsor ID
- 2023-0184
- Conditions
- Helicobacter Pylori Eradication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Apr 2024 (estimated)
- Study completion
- 21 Aug 2024 (estimated)
- First posted
- 23 May 2023 (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.
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.
Detailed description
The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
| Arm | Type | Receives |
|---|---|---|
| Recheck time is at 4 to 6 weeks after the eradication therapy | Placebo comparator | Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different timesAll cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 4 to 6 weeks( as guildeline suggested) after the treatment. |
| Recheck time is at 6 to 8 weeks after eradication therapy | Active comparator | Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different timesAll cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 6 to8 weeks after the treatment. |
| Recheck time is at 8 to 10 weeks after eradication therapy | Active comparator | Diagnostic Test: HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different timesAll cases are administered the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at 8 to 10 weeks after the treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no history of helicobacter pylori treatment
- the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.
Key exclusion criteria (7 listed)
- used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion.
- had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction.
- had a history of esophagectomy or gastrectomy.
- had an allergy to any study drug.
- had severe comorbidities or physical or mental diseases.
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 |
|---|---|---|
| HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different timesCarbon 13 breath tests are generally performed 4-6 weeks after eradication therapy. The control group will perform breath urea test at 4-6 weeks after treatment. The experimental groups will perform the same test at different times after the same treatment, 6-8weeks and 8-10 weeks, respectively. | Diagnostic test | Recheck time is at 4 to 6 weeks after the eradication therapy, Recheck time is at 6 to 8 weeks after eradication therapy, Recheck time is at 8 to 10 weeks after eradication therapy |
Primary outcome
the eradication rate in each group (ITT analysis)
Time frame: up to 4 months after eradication therapy
According to the breath urea test, calculation the eradication rate in the three groups. ITT analysis, the number of negative breath test cases after treatment divided by the number of cases enrolled in eradication therapy.
the eradication rate in each group (PP analysis)
Time frame: up to 4 months after eradication therapy
According to the breath urea test, calculation the eradication rate in the three groups. PP analysis, the number of negative breath test cases after treatment divided by the number of cases finished the eradication therapy
1 secondary outcome
follow up of cut off cases
Time frame: up to 4 months after eradication therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Jianting Cai, MD study chair
2nd Affilicated Hosptal,School of Medicine,Zhejiang University,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HY-IREXB plus carbon 13 breath detector do the breath urea test after eradication at different times in people with Helicobacter Pylori Eradication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 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 23 May 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. Some participants in this study may receive a placebo. 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 Yuehua Han, MD (+86057189713734, 13858126927@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the eradication rate in each group (ITT analysis) (time frame: up to 4 months after eradication therapy). The study lists 2 primary outcomes in all. 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 23 May 2023.