Helicobacter Pylori InfectionNCT07746934
Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
A study testing Metronidazole, Tinidazole 500mg and tetracyline in people with Helicobacter Pylori Infection, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This randomized, open-label clinical trial will compare two bismuth-containing quadruple therapies for the first-line treatment of Helicobacter pylori infection. Adults aged 18 years or older with confirmed H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Metronidazole, Tinidazole 500mg and tetracyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteVietnam
- Study dates
- 27 Jul 2026to 27 Dec 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Confirmed Helicobacter pylori infection
- Willing and able to provide written informed consent.
Who cannot join
- Pregnancy or breastfeeding.
- Gastrointestinal malignancy.
- Previous H. pylori eradication therapy.
- Liver cirrhosis.
- Stage IV or V chronic kidney disease.
- Previous gastric surgery.
- Known allergy to any study medication.
- Use of antibiotics within the previous 4 weeks.
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
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, 70000
Nhu Vu, +84-907513827, vuhanhnhu@ump.edu.vn
About this study
Official title: Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication
This randomized, open-label clinical trial will compare two bismuth-containing quadruple therapies for the first-line treatment of Helicobacter pylori infection. Adults aged 18 years or older with confirmed H. pylori infection who have not previously received eradication treatment will be randomly assigned in a 1:1 ratio to receive either a metronidazole-based regimen or a tinidazole-based regimen for 14 days. Both regimens will also include esomeprazole, tetracycline, and bismuth subcitrate.
The main purpose of the study is to determine whether the tinidazole-based regimen is not inferior to the metronidazole-based regimen in achieving successful H. pylori eradication. Eradication will be assessed after treatment using a carbon-13 urea breath test or an endoscopic urease test. The study will also compare adverse effects and treatment tolerability between the two groups. The results may help clinicians select the more appropriate nitroimidazole for bismuth quadruple therapy in routine clinical practice.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Metronidazole, Tinidazole 500mg, tetracyline, Bismuth Subcitrate, esomeprazole 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Metronidazole 500 mg orally three times daily after meals for 14 days, administered as part of bismuth quadruple therapy with esomeprazole 40 mg twice daily, tetracycline 500 mg four times daily, and bismuth subcitrate 120 mg four times daily.
Tinidazole 500mgDrug
Tinidazole 500 mg orally three times daily after meals for 14 days, administered as part of bismuth quadruple therapy with esomeprazole 40 mg twice daily, tetracycline 500 mg four times daily, and bismuth subcitrate 120 mg four times daily.
tetracylineDrug
Tetracyline 500 mg four times daily
Bismuth SubcitrateDrug
120 mg four times daily
esomeprazole 40 mgDrug
40 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole-Based Bismuth Quadruple Therapy | Active comparator | Not described Receives: Drug: Metronidazole; Drug: tetracyline; Drug: Bismuth Subcitrate; Drug: esomeprazole 40 mg |
| Tinidazole-Based Bismuth Quadruple Therapy | Experimental | Not described Receives: Drug: Tinidazole 500mg; Drug: tetracyline; Drug: Bismuth Subcitrate; Drug: esomeprazole 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori Eradication Rate
Measured: At least 4 weeks after completion of the 14-day eradication treatment
Secondary outcomes (1)
Side effects
Measured: During the 14-day eradication treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start27 Jul 2026 (estimated)
- Primary completion27 Aug 2027 (estimated)
- Study completion27 Dec 2027 (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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nhu Thi Hanh Vu, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746934
- Sponsor's protocol ID
- 2814/ĐHYD-HĐĐĐ
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No