Minocycline for Helicobacter Pylori Rescue Treatment

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: BQT; Drug: PBM4M4; Drug: PBM3M3; Drug: PBM2M4; Drug: PBM2M3

• Registration Number: NCT06332599
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-03-27
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 823

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BQT	BQT	-
PBM4M4	PBM4M4	-
PBM3M3	PBM3M3	-
PBM2M4	PBM2M4	-
PBM2M3	PBM2M3	-

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Rate of adverse effects	Within six weeks after completion of therapy	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
Compliance rate	Within six weeks after completion of therapy	Compliance was defined as poor when they had taken less than 80% of the total medication

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, None Selected, China