Helicobacter Pylori InfectionPhase 2/3NCT06591494
The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
A Phase 2/3 study testing Classic quadruple therapy, Quadruple therapy with sodium bicarbonate instead of bismuth and Quadruple therapy with sodium bicarbonate instead of clarithromycin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are: Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary… 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?
- Classic quadruple therapy, Quadruple therapy with sodium bicarbonate instead of bismuth and Quadruple therapy with sodium bicarbonate instead of clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 855 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 30 Dec 2025
- Phase
- Phase 2/3
- 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
- Aged 18-65 years, no history of eradication therapy;
- Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
- Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
- Voluntarily participate in clinical trials and sign informed consent.
Who cannot join
- Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
- Active peptic ulcer with complications such as bleeding, perforation or obstruction;
- History of esophagectomy or gastrectomy;
- Allergy to any study drug;
- Pregnancy or lactation;
- History of alcoholism or drug abuse;
- Mental illness;
- Incapacity for civil conduct.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are:
Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection?
Read more
Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection.
Participants will： Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Classic quadruple therapy, Quadruple therapy with sodium bicarbonate instead of bismuth, Quadruple therapy with sodium bicarbonate instead of clarithromycin
- Keywords
- Helicobacter pylori, Sodium Bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic quadruple therapyDrug
Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID
Quadruple therapy with sodium bicarbonate instead of bismuthDrug
Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID
Quadruple therapy with sodium bicarbonate instead of clarithromycinDrug
Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID
| Study group | Role | What they receive |
|---|---|---|
| Classic quadruple therapy | Active comparator | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days Receives: Drug: Classic quadruple therapy |
| Quadruple therapy with sodium bicarbonate instead of bismuth | Experimental | Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days Receives: Drug: Quadruple therapy with sodium bicarbonate instead of bismuth |
| Quadruple therapy with sodium bicarbonate instead of clarithromycin | Experimental | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID for 14 days Receives: Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Repeat 13C-UBT or 14C-UBT breath test, negative results (\<4.0‰, delta over baseline, 13C-UBT DOB; \<100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test.
Measured: 6-8 weeks after eradication treatment
Secondary outcomes (2)
Incidence of adverse reactions (AEs)
Participants\' symptoms during treatment, such as nausea, vomiting, diarrhea, rash, belching, abdominal pain, bloating, or other aggravated symptoms, were recorded and divided into three categories based on their impact on daily life: mild (transient, well tolerated), moderate (some discomfort that interferes with daily life), and severe (severe discomfort that adversely affects daily life).
Measured: One month after finishing with therapy
Compliance of patients
Good compliance was defined as taking at least 80% of the medication.
Measured: One month after finishing with therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 855 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591494
- Sponsor's protocol ID
- 2024-0814
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06591494
- Acronym / sponsor ID
- 2024-0814
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Sodium Bicarbonate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 855 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are:
Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection?
Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection.
Participants will： Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classic quadruple therapy | Active comparator | Drug: Classic quadruple therapyEsomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days |
| Quadruple therapy with sodium bicarbonate instead of bismuth | Experimental | Drug: Quadruple therapy with sodium bicarbonate instead of bismuthEsomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days |
| Quadruple therapy with sodium bicarbonate instead of clarithromycin | Experimental | Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycinEsomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID 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 (4 listed)
- Aged 18-65 years, no history of eradication therapy;
- Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
- Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
- Voluntarily participate in clinical trials and sign informed consent.
Key exclusion criteria (8 listed)
- Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
- Active peptic ulcer with complications such as bleeding, perforation or obstruction;
- History of esophagectomy or gastrectomy;
- Allergy to any study drug;
- Pregnancy or lactation;
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 |
|---|---|---|
| Classic quadruple therapyEsomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID | Drug | Classic quadruple therapy |
| Quadruple therapy with sodium bicarbonate instead of bismuthEsomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID | Drug | Quadruple therapy with sodium bicarbonate instead of bismuth |
| Quadruple therapy with sodium bicarbonate instead of clarithromycinEsomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID | Drug | Quadruple therapy with sodium bicarbonate instead of clarithromycin |
Primary outcome
Helicobacter pylori eradication rate
Time frame: 6-8 weeks after eradication treatment
Repeat 13C-UBT or 14C-UBT breath test, negative results (\<4.0‰, delta over baseline, 13C-UBT DOB; \<100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test.
2 secondary outcomes
Incidence of adverse reactions (AEs)
Time frame: One month after finishing with therapy
Compliance of patients
Time frame: One month after finishing with therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Classic quadruple therapy, Quadruple therapy with sodium bicarbonate instead of bismuth and Quadruple therapy with sodium bicarbonate instead of clarithromycin in people with Helicobacter Pylori Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jun Ye (13858168852 ext. 86, wzmcyejun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: 6-8 weeks after eradication treatment). 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 19 Sep 2024.