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Completed

NCT Number: NCT04879992

Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

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

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Proton pump inhibitor

Bismuth Potassium Citrate

Drug

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline,Metronidazole

Drug

Antibiotics for H. pylori eradication

amoxicillin rifabutin

Drug

Antibiotics for H. pylori eradication

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: Six weeks after completion of therapy

    Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was

Secondary outcomes

  1. Compliance rate

    Time frame: Within 7 days after completion of therapy

    Compliance was defined as poor when they had taken less than 80% of the total medication

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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