Doxycycline for Helicobacter Pylori Rescue Treatment

NCT05874570 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Phase 4

Started

2023-06-20

Last updated

2024-12-30

Condition(s) studied

Helicobacter Pylori Infection

Investigational drug(s) / intervention(s)

Esomeprazole →Bismuth Potassium CitrateTetracycline →Doxycycline →Metronidazole

Esomeprazole: Proton pump inhibitor

Bismuth Potassium Citrate: Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline: Antibiotics for H. pylori eradication

Doxycycline: Antibiotics for H. pylori eradication

Metronidazole: Antibiotics for H. pylori eradication

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Helicobacter pylori eradication rate — 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).

Trial sites (1)

Facility	City	Region	Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai Municipality	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05874570 on ClinicalTrials.gov ↗ ← All trials in China