Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline,Metronidazole; Drug: Vonoprazan; Drug: Minocycline,Metronidazole; Drug: Bismuth Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06561711

rjhy20240816

Details and patient eligibility

About

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 (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.

Enrollment: 476 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 experience

Exclusion criteria

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• Previous history of tuberculosis
• Allergy to any of the study drugs
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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476 participants in 4 patient groups

Minocycline group A

Experimental group

Description:

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid

Treatment:

Drug: Minocycline,Metronidazole

Drug: Bismuth Potassium Citrate

Drug: Vonoprazan

Minocycline group B

Experimental group

Description:

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid

Treatment:

Drug: Minocycline,Metronidazole

Drug: Bismuth Potassium Citrate

Drug: Vonoprazan

Minocycline group C

Experimental group

Description:

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid

Treatment:

Drug: Minocycline,Metronidazole

Drug: Bismuth Potassium Citrate

Drug: Vonoprazan

Tetracycline group

Active Comparator group

Description:

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Vonoprazan

Drug: Tetracycline,Metronidazole