Comparing tailored therapy to standard treatment for Helicobacter pylori infection
Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study
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 |
| Enrollment | 450 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05332444 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with susceptibility-guided therapy approaches, indicating potential for success in this area.
Eligibility criteria
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 this trial is running
Taipei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.