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
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of 14-day bismuth-containing quadruple rescue therapies for people with Helicobacter pylori infection who have not been successfully treated before. The study focuses on replacing tetracycline with doxycycline to address tetracycline's unavailability in China and the high rate of side effects that reduce treatment adherence. This is a randomized controlled trial sponsored by Shanghai Jiao Tong University School of Medicine to assess effectiveness and tolerability. Participants receive either esomeprazole, bismuth potassium citrate, tetracycline, and metronidazole or esomeprazole, bismuth potassium citrate, doxycycline, and metronidazole. The treatments are given over 14 days with specific dosages and schedules: esomeprazole twice daily, bismuth four times daily, metronidazole four times daily, and either tetracycline four times daily or doxycycline twice daily. This setup allows comparison of the two regimens as rescue therapies. During the trial, participants are monitored for treatment effectiveness by checking Helicobacter pylori eradication six weeks after therapy ends. Researchers also assess adverse effects and how well participants follow the treatment within seven days after finishing therapy. The total participation period includes treatment and follow-up visits to evaluate these outcomes and ensure safety.
CONDITIONS
Brief 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 old
You will not qualify if you...
- No prior Helicobacter pylori treatment (treatment naive)
- Age under 18 or over 80 years old
- History of gastrectomy
- Pregnant or lactating women
- Severe systemic diseases or malignancy
- Use of antibiotics, bismuth, antisecretory drugs, or Chinese herbal medicine in the preceding 8 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive one of two drug regimens containing esomeprazole, bismuth potassium citrate, and antibiotics including tetracycline or doxycycline to eradicate Helicobacter pylori infection.
Daily medication during treatment period with assessment visits within 7 days after completion
Duration - 6 weeks after completion of therapy
Participants are monitored for Helicobacter pylori eradication and any adverse effects following treatment completion.
1 visit (in-person) approximately 6 weeks after treatment ends
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
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