Comparing 7-day and 14-day treatments for Helicobacter pylori infection
Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori : A Multicenter Randomized Non-Inferiority Trial
NA · Shandong University · NCT05997433
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05997433 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated that shorter courses of bismuth quadruple therapy can be effective, suggesting that this approach may yield similar success.
Eligibility criteria
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 this trial is running
Jinan, Shandong
- 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
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.
Conditions: Helicobacter Pylori Infection