Skip to content

Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04879992
Enrollment
413
Registered
2021-05-10
Start date
2021-05-07
Completion date
2022-10-30
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori Therapy

Brief 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

Interventions

DRUGEsomeprazole

Proton pump inhibitor

DRUGBismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Antibiotics for H. pylori eradication

DRUGamoxicillin rifabutin

Antibiotics for H. pylori eradication

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Helicobacter pylori eradication rateSix weeks after completion of therapySix weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was

Secondary

MeasureTime frameDescription
Compliance rateWithin 7 days after completion of therapyCompliance was defined as poor when they had taken less than 80% of the total medication

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026