Comparing 7-day and 14-day treatments for Helicobacter pylori infection
Official title: Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori : A Multicenter Randomized Non-Inferiority Trial
Run by Shandong University · NCT05997433 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether a 7-day treatment for Helicobacter pylori infection works as well as a 14-day treatment for people who have this common stomach issue.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 254 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05997433 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-70 who have a confirmed H. pylori infection and have not previously undergone eradication therapy.
✕Probably not a fit
Patients with serious underlying health conditions, pregnant or lactating women, or those with a history of gastrointestinal surgery 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 clinical trial evaluates the effectiveness of two different durations of bismuth quadruple therapy for eradicating Helicobacter pylori infection, a common gastrointestinal issue. Participants who test positive for H. pylori will be randomly assigned to receive either a 7-day or a 14-day course of treatment. After the treatment period, patients will undergo a breath test to assess the success of the eradication therapy, and the study will compare the eradication rates, adverse reactions, and patient compliance between the two groups. The goal is to determine if the shorter treatment duration is as effective as the longer one.
Why it matters
Potential benefit: If successful, this study could lead to a shorter and potentially safer treatment option for patients with H. pylori infection.
How similar studies have gone: Previous studies have indicated that shorter courses of bismuth quadruple therapy can be effective, suggesting that this approach may yield similar success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-70. 2. Without active hepatitis. 3. Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath test). 4. Patients who have not previously received helicobacter pylori eradication therapy. Exclusion Criteria: 1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%. 2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial. 3. Patients with active gastrointestinal bleeding. 4. Patients with a history of upper gastrointestinal surgery. 5. Patients allergic to treatment drugs. 6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks. 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse. 8. Patients who are unwilling or incapable to provide informed consents.
Where it's running
-
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: Yanqing Li, Ph.D — Qilu Hospital of Shandong University
- Study coordinator: Yanqing Li, Ph.D
- Email: liyanqing@sdu.edu.cn
- Phone: +8653188369277
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
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.