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NCT04879992 Clinical Trial

Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:
Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04879992
Other study ID # rjcjn20210506
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 7, 2021
Est. completion date October 30, 2022

Study information
Verified date November 2022
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori

Recruitment information / eligibility
Status Completed
Enrollment 413
Est. completion date October 30, 2022
Est. primary completion date October 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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: - Less than 18 years old - With previous gastric surgery - Previous history of tuberculosis - Major systemic diseases - Pregnancy or lactation - Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
• Tetracycline,Metronidazole
Antibiotics for H. pylori eradication
• amoxicillin rifabutin
Antibiotics for H. pylori eradication

Locations
Country Name City State
China Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Helicobacter pylori eradication rate Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was Six weeks after completion of therapy
Secondary Compliance rate Compliance was defined as poor when they had taken less than 80% of the total medication Within 7 days after completion of therapy
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