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Completed

NCT Number: NCT06561711

Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

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.

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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

Peking University Third Hospital, Beijing, Beijing 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 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

Treatment and study plan

Vonoprazan

Drug

Potassium competitive acid blocker

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). In addition, blood test were messured to access function of liver and kidney.

  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

Optimization of Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Multicentre, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Mar 25, 2026

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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