Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

Официальное название

Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

Обзор

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.

Подробное описание

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma, and is classified as a Group I carcinogen by the World Health Organization. The "2022 Chinese Clinical Guidelines for the Treatment of Helicobacter pyloriInfection" recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive (no endoscopy required), rapid (significantly shorter turnaround time), and accurate (direct detection of resistance genes), thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.

Вмешательства

• Препарат Personalized treatment based on the results of fecal antimicrobial resistance gene testing
  Personalized treatment: Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin); Patients resistant to clarithromycin but sensitive to levofloxacin are assigned to the Levofloxacin Group (receiving vonoprazan, amoxicillin, and levofloxacin); Patients resistant to both clarithromycin and levofloxacin are assigned to the Tetracycline Group (receiving vonoprazan, amoxicillin, and tetracycline). The treatmen
• Препарат Conventional Quadruple Therapy
  Conventional Quadruple Therapy： Vonoprazan 20mg BID; Colloidal Bismuth Pectin 220mg BID; Amoxicillin 1.0g BID; tetracycline 0.5g TID. Treatment duration: 14 days.

Первичные конечные точки

• H. pylori eradication rate [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Вторичные конечные точки (1)

• Adverse effect of the treatment [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

• ① Age 18-70 years;

• Patients with Hp-positive chronic gastritis who have failed initial treatment, as confirmed by urea breath test or endoscopic biopsy;

• No use of PPIs, H2-receptor antagonists, antibiotics, or bismuth agents within 4 weeks;

• History of having received one previous, standardized Hp eradication therapy.

Критерии исключения

• ① Use of antibiotics, bismuth agents within 4 weeks prior to treatment, or use of PPIs or H₂-receptor antagonists within 2 weeks prior to treatment;

• History of gastric or duodenal surgery;

• Concurrent presence of other serious conditions such as cardiac, hepatic, or renal dysfunction, malignant tumors, or other severe internal diseases;

• Allergy to any component of the study medications; ⑤ Pregnant or breastfeeding women; ⑥ Participation in other drug studies within 3 months prior to treatment; ⑦ Patients unable to accurately express their complaints or cooperate with the study investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07533422 · 2025-1670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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