Helicobacter Pylori InfectionNCT07260006
Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
A study testing Bismuth quadruple therapy and Triple therapy with PPI + Amoxicillin + Metronidazole in people with Helicobacter Pylori Infection and Peptic Ulcer, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children. The main questions it aims to answer are: Does a treatment plan with bismuth work better than a plan without bismuth to clear the infection? Is… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer
- What is being tested?
- Bismuth quadruple therapy and Triple therapy with PPI + Amoxicillin + Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with gastritis or peptic ulcer disease by upper gastrointestinal endoscopy or histopathology.
- Meets diagnostic criteria for Helicobacter pylori infection.
- Parent or legal guardian provides consent for the child to participate in the study.
Who cannot join
- Allergic to any of the medications in the treatment regimen.
- Use of antibiotics or bismuth within the past 4 weeks, or use of antacids, H2-receptor antagonists, or proton pump inhibitors within the past 2 weeks.
- Failure to return for follow-up visits after treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Can Tho Children's Hospital
Can Tho, 900000
Loan Thi Thuy Le, MD, PhD, +84 914 375 231, lttloan@ctump.edu.vn
Trang Thuy Mai, MD
About this study
Official title: A Study on the Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
The goal of this clinical trial is to learn if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children.
The main questions it aims to answer are:
Read more
- Does a treatment plan with bismuth work better than a plan without bismuth to clear the infection?
- Is the bismuth plan more cost-effective while still safe and effective?
Researchers will compare two treatment groups to see which works better. Participants will:
- Take one of the two assigned treatment plans (with or without bismuth) for the standard treatment duration
- Visit the clinic for checkups and tests to confirm infection clearance and monitor side effects
- Keep a diary of symptoms, medication use, and any side effects
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer
- Being tested
- Bismuth quadruple therapy, Triple therapy with PPI + Amoxicillin + Metronidazole
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth quadruple therapyDrug
A 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight.
Triple therapy with PPI + Amoxicillin + MetronidazoleDrug
A 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), amoxicillin, and metronidazole.
All drug doses are adjusted according to the participant's age and weight.
| Study group | Role | What they receive |
|---|---|---|
| Bismuth quadruple therapy | Experimental | Patients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age. Receives: Drug: Bismuth quadruple therapy |
| Triple therapy with PPI + Amoxicillin + Metronidazole | Experimental | Patients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age. Receives: Drug: Triple therapy with PPI + Amoxicillin + Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori infection between the two treatment regimens
The efficacy of the two regimens will be evaluated by comparing H. pylori eradication rates. Clinical examination and a urea breath test or stool antigen test will be performed after completion of therapy to confirm eradication. Patients will receive a 14-day treatment regimen, followed by an additional 2-4 weeks of proton pump inhibitor (PPI) therapy to promote healing of gastric or duodenal lesions.
Measured: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Oct 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Thùy Trang, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260006
- Sponsor's protocol ID
- 2317/QD-DHYDCT
- Status last verified
- Jul 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
- ClinicalTrials.gov ID
- NCT07260006
- Acronym / sponsor ID
- 2317/QD-DHYDCT
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 2 Dec 2025 (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 if including bismuth in the treatment helps heal stomach and duodenal ulcers caused by Helicobacter pylori (H. pylori) in children.
The main questions it aims to answer are:
- Does a treatment plan with bismuth work better than a plan without bismuth to clear the infection?
- Is the bismuth plan more cost-effective while still safe and effective?
Researchers will compare two treatment groups to see which works better. Participants will:
- Take one of the two assigned treatment plans (with or without bismuth) for the standard treatment duration
- Visit the clinic for checkups and tests to confirm infection clearance and monitor side effects
- Keep a diary of symptoms, medication use, and any side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bismuth quadruple therapy | Experimental | Drug: Bismuth quadruple therapyPatients in this arm will receive PPI, Amoxicillin, Metronidazole, and Bismuth for 14 days, with doses adjusted according to weight and age. |
| Triple therapy with PPI + Amoxicillin + Metronidazole | Experimental | Drug: Triple therapy with PPI + Amoxicillin + MetronidazolePatients in this arm will receive PPI, Amoxicillin, Metronidazole for 14 days, with doses adjusted according to weight and age. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed with gastritis or peptic ulcer disease by upper gastrointestinal endoscopy or histopathology.
- Meets diagnostic criteria for Helicobacter pylori infection.
- Parent or legal guardian provides consent for the child to participate in the study.
Key exclusion criteria (3 listed)
- Allergic to any of the medications in the treatment regimen.
- Use of antibiotics or bismuth within the past 4 weeks, or use of antacids, H2-receptor antagonists, or proton pump inhibitors within the past 2 weeks.
- Failure to return for follow-up visits after treatment.
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 |
|---|---|---|
| Bismuth quadruple therapyA 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight. | Drug | Bismuth quadruple therapy |
| Triple therapy with PPI + Amoxicillin + MetronidazoleA 14-day regimen including proton pump inhibitor (PPI; esomeprazole [Nexium MUPS]), amoxicillin, and metronidazole. All drug doses are adjusted according to the participant's age and weight. | Drug | Triple therapy with PPI + Amoxicillin + Metronidazole |
Primary outcome
Eradication rate of Helicobacter pylori infection between the two treatment regimens
Time frame: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.
The efficacy of the two regimens will be evaluated by comparing H. pylori eradication rates. Clinical examination and a urea breath test or stool antigen test will be performed after completion of therapy to confirm eradication. Patients will receive a 14-day treatment regimen, followed by an additional 2-4 weeks of proton pump inhibitor (PPI) therapy to promote healing of gastric or duodenal lesions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth quadruple therapy and Triple therapy with PPI + Amoxicillin + Metronidazole in people with Helicobacter Pylori Infection and Peptic Ulcer, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trang Thuy Mai, MD (+84 838 857 890, maithuytrang2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori infection between the two treatment regimens (time frame: Two weeks after discontinuation of acid suppression therapy following completion of the eradication regimen.). 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 2 Dec 2025.