Doxycycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- Helicobacter pylori eradication rate
Study Overview
Brief Summary
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by doxycycline.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Confirmed H. pylori infection and with previous treatment failure
Exclusion Criteria
- •subjects naive to H. pylori treatment,
- •under 18 or over 80 years old
- •history of gastrectomy
- •pregnant or lactating women
- •severe systemic diseases or malignancy
- •administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Arms & Interventions
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Intervention: Esomeprazole (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Intervention: Bismuth Potassium Citrate (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Intervention: Tetracycline (Drug)
Tetracycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Intervention: Metronidazole (Drug)
Doxycycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid
Intervention: Esomeprazole (Drug)
Doxycycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid
Intervention: Bismuth Potassium Citrate (Drug)
Doxycycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid
Intervention: Doxycycline (Drug)
Doxycycline Bismuth Quadruple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid
Intervention: Metronidazole (Drug)
Outcomes
Primary Outcomes
Helicobacter pylori eradication rate
Time Frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Secondary Outcomes
- Rate of adverse effects(Within 7 days after completion of therapy)
- Compliance rate(Within 7 days after completion of therapy)
Investigators
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
RenJi Hospital