Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Sodium Bicarbonate
Brief summary
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
Interventions
DRUGClassic quadruple therapy
Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID
DRUGQuadruple therapy with sodium bicarbonate instead of bismuth
Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID
DRUGQuadruple 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
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | 6-8 weeks after eradication treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions (AEs) | One month after finishing with therapy | 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). |
| Compliance of patients | One month after finishing with therapy | Good compliance was defined as taking at least 80% of the medication. |
Contacts
Primary ContactJun Ye
Outcome results
None listed