Minocycline for Helicobacter Pylori Rescue Treatment

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: BQT; Drug: PBM4M4; Drug: PBM2M3; Drug: PBM3M3; Drug: PBM2M4

Study type: Observational

Funder types: Other

Identifiers

NCT06332599

rjhy20240001

Details and patient eligibility

About

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. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.

Enrollment: 823 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed H. pylori infection and with previous treatment failure

Exclusion criteria

• subjects naive to H. pylori treatment,
• 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 12 weeks

Trial design

823 participants in 5 patient groups

BQT

Treatment:

Drug: BQT

PBM4M4

Treatment:

Drug: PBM4M4

PBM3M3

Treatment:

Drug: PBM3M3

PBM2M4

Treatment:

Drug: PBM2M4

PBM2M3

Treatment:

Drug: PBM2M3