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Evaluation of the Efficacy and Safety of the Quadruple Therapy with Brachyspira Yeast and Bismuth in Eradicating Helicobacter pylori: A Prospective, Randomized, Open-Label Controlled Study.

Evaluation of the Efficacy and Safety of the Quadruple Therapy with Brachyspira Yeast and Bismuth in Eradicating Helicobacter pylori: A Prospective, Randomized, Open-Label Controlled Study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079593
Enrollment
Unknown
Registered
2024-01-08
Start date
2024-01-11
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori

Interventions

Experimental Group: Rabeprazole 20 mg twice daily (Bid) + Amoxicillin 1 g Bid + Clarithromycin 500 mg Bid + Potassium Citrate Bismuth 220 mg Bid + Brachyspira Yeast 0.25 g Bid. :Rabeprazole 20 mg twi
Control Group: Rabeprazole 20 mg Bid + Amoxicillin 1 g Bid + Clarithromycin 500 mg Bid + Potassium Citrate Bismuth 220 mg Bid.:Control Group: Rabeprazole 20 mg Bid + Amoxicillin 1 g Bid + Clarithromyc

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: a. Age 18-70 years. b. Confirmed presence of H. pylori infection through any of the following testing methods: 13C or 14C urea breath test, tissue pathology immunohistochemical staining, H. pylori culture, fecal H. pylori antigen testing. c. Patients undergoing their first H. pylori eradication treatment. d. Willingness to undergo H. pylori treatment and sign the relevant informed consent form.

Exclusion criteria

Exclusion criteria: a. Allergic to any drug used in the treatment plan. b. History of gastric surgery. c. Patients with active digestive ulcers accompanied by bleeding. d. Presence of severe dysfunction in vital organs such as respiratory, cardiac, liver, or kidney. e. Use of bismuth, antibiotics, and antimicrobial Chinese medicine in the 4 weeks prior to enrollment, and use of potassium-competitive acid blockers, PPIs, H2 receptor antagonists, and NSAIDs in the 2 weeks prior to treatment. f. Pregnant or lactating women. g. Individuals with alcohol or drug addiction, or severe neurocognitive disorders.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Compliance;Intestinal microbiota;

Countries

China

Contacts

Public ContactWei-Feng Huang

The First Affiliated Hospital of Xiamen University

hwf0625@163.com+86 181 5090 6129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026