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

NCT06591494 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-0814
• Study Type: interventional
• Target: 855
• Locations: 0 countries
• Sites: N/A

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Sodium Bicarbonate

Outcome Measures

Primary Outcomes (1)

• 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.

  6-8 weeks after eradication treatment

Secondary Outcomes (2)

• Incidence of adverse reactions (AEs)

  One month after finishing with therapy

• Compliance of patients

  One month after finishing with therapy

Study Arms (3)

Classic quadruple therapy

ACTIVE COMPARATOR

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days

Drug: Classic quadruple therapy

Quadruple therapy with sodium bicarbonate instead of bismuth

EXPERIMENTAL

Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days

Drug: Quadruple therapy with sodium bicarbonate instead of bismuth

Quadruple therapy with sodium bicarbonate instead of clarithromycin

EXPERIMENTAL

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID for 14 days

Drug: Quadruple therapy with sodium bicarbonate instead of clarithromycin

Interventions

Classic quadruple therapy DRUG

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID

Classic quadruple therapy

Quadruple therapy with sodium bicarbonate instead of bismuth DRUG

Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID

Quadruple therapy with sodium bicarbonate instead of bismuth

Quadruple therapy with sodium bicarbonate instead of clarithromycin DRUG

Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID

Quadruple therapy with sodium bicarbonate instead of clarithromycin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

Jun Ye

CONTACT

13858168852; wzmcyejun@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09