NCT05461508

Fucoidan Assisted Eradication of Helicobacter Pylori

Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 60 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg TID, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 44th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.

Conditions

• Helicobacter Pylori Infection
• Intestinal Bacteria Flora Disturbance

Interventions

Type	Name	Description
BIOLOGICAL	Amoxicillin combined with vonoprazan and fucoidan	Fucoidan was used in combination with amoxicillin and vonoprazan. The purpose of this study was to explore the effect of fucoidan on the eradication rate of Helicobacter pylori and the intestinal flora of subjects.
OTHER	Amoxicillin combined with vonoprazan	Amoxicillin and vonoprazan were used as the study control group

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-06-01
• Completion: 2024-07-31
• First posted: 2022-07-18
• Last updated: 2023-12-07

Locations

1 site across 1 country: China