Actively Recruiting
Doxycycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment A Randomized Controlled Trial
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-12-30
368
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and tolerability of a 14-day bismuth-containing quadruple therapy for Helicobacter pylori infection rescue treatment. This therapy replaces tetracycline with doxycycline due to limited availability of tetracycline in China and the common side effects associated with the traditional quadruple therapy. The study is a Phase 4 randomized controlled trial aiming to improve treatment options for patients who have failed previous H. pylori therapies. The study compares two treatment regimens both containing esomeprazole (a proton pump inhibitor), bismuth potassium citrate (a gastric mucosal protective drug with anti-H. pylori effect), metronidazole (an antibiotic), and either tetracycline or doxycycline (both antibiotics for H. pylori eradication). Participants receive these treatments for 14 days as rescue therapy. The main goal is to assess the eradication rate of H. pylori six weeks after completing therapy. Participants will be involved in treatment administration and monitored for eradication success and side effects. Researchers will measure the primary outcome of Helicobacter pylori eradication rate six weeks post-treatment. Safety and tolerability will also be observed throughout the study. The total duration includes treatment and follow-up periods to evaluate the treatment's effectiveness and patient compliance.
CONDITIONS
Official Title
Doxycycline for Helicobacter Pylori Rescue Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed Helicobacter pylori infection with previous treatment failure
- Age between 18 and 70 years
You will not qualify if you...
- Never treated before for Helicobacter pylori infection
- Younger than 18 or older than 80 years
- History of stomach removal surgery (gastrectomy)
- Pregnant or breastfeeding women
- Severe systemic diseases or cancer
- Use of antibiotics, bismuth, antisecretory drugs, or Chinese herbal medicine within the last 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here