Doxycycline for Helicobacter Pylori Rescue Treatment
Doxycycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
1 other identifier
interventional
368
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2023
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedDecember 30, 2024
December 1, 2024
2.3 years
May 16, 2023
December 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Helicobacter pylori eradication rate
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).
Six weeks after completion of therapy
Secondary Outcomes (2)
Rate of adverse effects
Within 7 days after completion of therapy
Compliance rate
Within 7 days after completion of therapy
Study Arms (2)
Tetracycline Bismuth Quadruple Therapy
ACTIVE COMPARATOREsomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Doxycycline Bismuth Quadruple Therapy
EXPERIMENTALEsomeprazole 20mg bid, Bismuth Potassium Citrate 110mg qid, Doxycycline 100mg bid, Metronidazole 400mg qid
Interventions
Proton pump inhibitor
Gastric mucosal protective drug with anti-H. pylori effect
Antibiotics for H. pylori eradication
Eligibility Criteria
You may qualify if:
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment failure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Study Record Dates
First Submitted
May 16, 2023
First Posted
May 25, 2023
Study Start
June 20, 2023
Primary Completion
October 10, 2025
Study Completion
October 31, 2025
Last Updated
December 30, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share