Helicobacter Pylori; Eradication RateNCT05301725
Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori
An observational study of Helicobacter Pylori; Eradication Rate, run by Shandong University at 1 site in China.
Trial summary
Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori; Eradication Rate
- What is being tested?
- PPI regimen and P-CAB regimen
- How many people
- 670 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2021
- Phase
- Observational
- 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
Study population: helicobacter infection
Who may be able to join
- Participants aged 18-75 years with persistent H. pylori infection.
- Participants received clarithromycin-based bismuth-containing quadruple therapy.
Who cannot join
- Patients received rescue therapy
- Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
- Patients with gastorectomy
- Currently pregnant or lactating or other conditions unable to receive therapy
- 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
- Severe neurologic or psychiatric disorders
- Information incomplete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy as First-line Treatment Against Helicobacter Pylori
Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.
Read the detailed description
This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.
- Conditions
- Helicobacter Pylori; Eradication Rate
- Being tested
- PPI regimen, P-CAB regimen
- Keywords
- Helicobacter pylori,eradication therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI regimenOther
All patients received PPI regimen( lansoprazole or esomeprazole,bismuth amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.
P-CAB regimenOther
All patients received P-CAB regimen(vonoprazan,bismuth ,amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.
| Study group | Role | What they receive |
|---|---|---|
| PPI group | PPI regimen Receives: Other: PPI regimen | |
| P-CAB group | P-CAB regimen Receives: Other: P-CAB regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eradication success
Six weeks after completion of treatment, numbers 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 (ITT) analysis, modified intention to treat analysis (MITT) and per-protocol (PP) analysis. The ITT analysis includes all the patients who take at least one dose of the study medications. The MITT analysis is limited to patients who complete follow-up.The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Measured: 1 month
Prevalence of adverse events
At the follow-up, adverse events complained by patients will be recorded by an independent researcher, meanwhile CTCAE v5.0 was used to evaluate severity of adverse events.The prevalence of adverse events was compared between the two group
Measured: 1 month
Number of participants with good compliance
Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good whenmore than 90% or less than 120% of the total pills were taken
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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; 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 670 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
- NCT05301725
- Sponsor's protocol ID
- 2022-SDU-QILU-G001
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang J, Li YY, Lin MJ, Liu J, Lin BS, Ding YM, Wan M, Zhang WL, Kong QZ, Wang ST, Mu YJ, Duan M, Han ZX, Zuo XL, Li YQ. Vonoprazan is noninferior to proton pump inhibitors in bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: A propensity score matching analysis. J Dig Dis. 2023 Jan;24(1):19-27. doi: 10.1111/1751-2980.13166. Epub 2023 Apr 22.
PubMed 36960538
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy as First-line Treatment Against Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT05301725
- Acronym / sponsor ID
- 2022-SDU-QILU-G001
- Conditions
- Helicobacter Pylori; Eradication Rate
- Keywords
- Helicobacter pylori,eradication therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Mar 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.
Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.
Detailed description
This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI group | – | Other: PPI regimenPPI regimen |
| P-CAB group | – | Other: P-CAB regimenP-CAB regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- helicobacter infection
Key inclusion criteria (2 listed)
- Participants aged 18-75 years with persistent H. pylori infection.
- Participants received clarithromycin-based bismuth-containing quadruple therapy.
Key exclusion criteria (7 listed)
- Patients received rescue therapy
- Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
- Patients with gastorectomy
- Currently pregnant or lactating or other conditions unable to receive therapy
- 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 |
|---|---|---|
| PPI regimenAll patients received PPI regimen( lansoprazole or esomeprazole,bismuth amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved. | Other | PPI group |
| P-CAB regimenAll patients received P-CAB regimen(vonoprazan,bismuth ,amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved. | Other | P-CAB group |
Primary outcome
Rate of eradication success
Time frame: 1 month
Six weeks after completion of treatment, numbers 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 (ITT) analysis, modified intention to treat analysis (MITT) and per-protocol (PP) analysis. The ITT analysis includes all the patients who take at least one dose of the study medications. The MITT analysis is limited to patients who complete follow-up.The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Prevalence of adverse events
Time frame: 1 month
At the follow-up, adverse events complained by patients will be recorded by an independent researcher, meanwhile CTCAE v5.0 was used to evaluate severity of adverse events.The prevalence of adverse events was compared between the two group
Number of participants with good compliance
Time frame: 1 month
Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good whenmore than 90% or less than 120% of the total pills were taken
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 Mar 2022.
- Derived from this study: PubMed 36960538Wang J, Li YY, Lin MJ, Liu J, Lin BS, Ding YM, Wan M, Zhang WL, Kong QZ, Wang ST, Mu YJ, Duan M, Han ZX, Zuo XL, Li YQ. Vonoprazan is noninferior to proton pump inhibitors in bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: A propensity score matching analysis. J Dig Dis. 2023 Jan;24(1):19-27. doi: 10.1111/1751-2980.13166. Epub 2023 Apr 22.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of 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 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
Rate of eradication success (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT05301725, 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 Mar 2022.