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

Phase 3Not Yet RecruitingNCT06591494

Second Affiliated Hospital, Zhejiang University, School of Medicine855 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

855

Conditions

Helicobacter Pylori Infection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

Repeat 13C-UBT or 14C-UBT breath test, negative results (\<4.0‰, delta over baseline, 13C-UBT DOB; \<100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test.

Time frame: 6-8 weeks after eradication treatment

Secondary Outcomes

Incidence of adverse reactions (AEs)

Participants\' symptoms during treatment, such as nausea, vomiting, diarrhea, rash, belching, abdominal pain, bloating, or other aggravated symptoms, were recorded and divided into three categories based on their impact on daily life: mild (transient, well tolerated), moderate (some discomfort that interferes with daily life), and severe (severe discomfort that adversely affects daily life).

Time frame: One month after finishing with therapy

Compliance of patients

Good compliance was defined as taking at least 80% of the medication.