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Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

NCT ID: NCT06561711

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori rescue therapy minocycline tetracycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minocycline group A

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

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Minocycline group B

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

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Minocycline group C

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

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Tetracycline group

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

Group Type ACTIVE_COMPARATOR

Vonoprazan

Intervention Type DRUG

Potassium competitive acid blocker

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

Interventions

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Vonoprazan

Potassium competitive acid blocker

Intervention Type DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Tetracycline,Metronidazole

Antibiotics for H. pylori eradication

Intervention Type DRUG

Minocycline,Metronidazole

Antibiotics for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhiqiang Song, Ph.D

Role: primary

Yu Huang, Master

Role: primary

Hong Lu, Ph.D

Role: backup

Jing Wang, Ph.D

Role: primary

Yaohua Han, Ph.D

Role: primary

Other Identifiers

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rjhy20240816

Identifier Type: -

Identifier Source: org_study_id