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Completed

NCT Number: NCT04531059

Rescue Therapy for Helicobacter Pylori Eradication Treatment

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. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

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Key information

Conditions

Helicobacter Pylori Infection cyclopia sequence

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China

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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 failure

Exclusion criteria

  • subjects naive to H. pylori treatment,
  • under 18 or over 80 years old
  • 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 8 weeks
  • contraindications to the study drugs

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

Minocycline,Metronidazole

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 defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).

Secondary outcomes

  1. Rate of adverse effects

    Time frame: Within 7 days 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)

  2. 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

Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2020
Registry last updated
Dec 30, 2024

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

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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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