Comparing tailored therapy to standard treatment for Helicobacter pylori infection
Official title: Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study
Run by National Taiwan University Hospital · NCT05332444 · Data updated 2026-11-12
This study is testing if a personalized treatment plan for Helicobacter pylori infection works better than the standard treatment for people who haven't had success with previous therapies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | April 11, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT05332444 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 20 and older with H. pylori-positive chronic gastritis and a history of treatment failure.
✕Probably not a fit
Patients who are pregnant, nursing, or have serious concomitant illnesses or a history of hypersensitivity to the test drugs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of susceptibility-guided tailored therapy (SG-TT) versus guidelines-recommended empiric therapy (GR-ET) for patients with Helicobacter pylori infection who have previously failed treatment. It will involve a multicenter, randomized approach where patients will be assigned to one of the two treatment groups based on a randomization process. The study will also assess patient adherence, adverse effects, and factors influencing treatment success. Participants will be monitored throughout the treatment period to gather data on symptoms and medication use.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from Helicobacter pylori infections, particularly those who have not responded to previous therapies.
How similar studies have gone: Other studies have shown promising results with susceptibility-guided therapy approaches, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients, aged \>= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Exclusion Criteria: 1. pregnant or nursing woman; 2. serious concomitant illness and malignant tumor of any kind; 3. history of hypersensitivity to test drugs; 4. serious bleeding during the course of this ulcer; 5. previous gastric surgery; 6. receiving bismuth salts, PPIs, or antibiotics in the previous month.
Where it's running
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National Taiwan University Hospital
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: Jyh-Chin Yang, M.D.Ph.D. — National Taiwan University Hospital
- Study coordinator: Jyh-Chin Yang, M.D.Ph.D.
- Email: jcyang47@ntu.edu.tw
- Phone: 02-23123456
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Fecal transplant to help eradicate stubborn Helicobacter pylori infection
This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.
-
Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori
We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.
-
Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection
This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.
-
P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection
This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.
-
Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children
This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.
-
Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.