The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection

Обзор

The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are: Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection. Participants will： Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance

Вмешательства

• Препарат Classic quadruple therapy
  Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID
• Препарат Quadruple therapy with sodium bicarbonate instead of bismuth
  Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID
• Препарат Quadruple therapy with sodium bicarbonate instead of clarithromycin
  Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID

Первичные конечные точки

• Helicobacter pylori eradication rate [Срок оценки: 6-8 weeks after eradication treatment]

Вторичные конечные точки (2)

• Incidence of adverse reactions (AEs) [Срок оценки: One month after finishing with therapy]
• Compliance of patients [Срок оценки: One month after finishing with therapy]

Критерии участия

Критерии включения

• Aged 18-65 years, no history of eradication therapy;
• Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
• Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
• Voluntarily participate in clinical trials and sign informed consent.

Критерии исключения

• Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
• Active peptic ulcer with complications such as bleeding, perforation or obstruction;
• History of esophagectomy or gastrectomy;
• Allergy to any study drug;
• Pregnancy or lactation;
• History of alcoholism or drug abuse;
• Mental illness;
• Incapacity for civil conduct.

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: NCT06591494 · 2024-0814

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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