Doxycycline for Helicobacter Pylori Rescue Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esomeprazole, Bismuth Potassium Citrate, Tetracycline, Doxycycline.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Doxycycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
Overview
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.
Interventions
- Drug Esomeprazole
Proton pump inhibitor - Drug Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect - Drug Tetracycline
Antibiotics for H. pylori eradication - Drug Doxycycline
Antibiotics for H. pylori eradication - Drug Metronidazole
Antibiotics for H. pylori eradication
Primary outcome measures
- Helicobacter pylori eradication rate [Time frame: Six weeks after completion of therapy]
Secondary outcome measures (2)
- Rate of adverse effects [Time frame: Within 7 days after completion of therapy]
- Compliance rate [Time frame: Within 7 days after completion of therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT05874570 · rjhy20230002