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.

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Intestinal Bacteria Flora Disturbance
• Intervention / Treatment: Other: Amoxicillin combined with vonoprazan; Biological: Amoxicillin combined with vonoprazan and fucoidan

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing First Hospital, Nanjing Medical University
      • Contact: Zhenyu Zhang, Master; Phone Number: +8618951670222; Email: zzy6565@sina.com
      • Contact: Wenjuan Wei, Doctor; Phone Number: +8618851009006; Email: wjwei.hf@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-65 years old;
2. Patients diagnosed as HP positive;
3. Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
4. Voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergic to the study drug (penicillin allergy, etc.);
2. Patients with chronic gastritis and peptic ulcer;
3. Patients who have received HP eradication treatment within half a year;
4. Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
5. Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
6. History of esophageal or gastric surgery;
7. Pregnant and lactating women;
8. Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amoxicillin combined with vonoprazan; The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days	Other: Amoxicillin combined with vonoprazan; Amoxicillin and vonoprazan were used as the study control group
Experimental: Amoxicillin combined with vonoprazan and fucoidan; The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and fucoidan 1000mg twice a day. These three drugs were taken continuously for 14 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare eradication rates of the two groups by 13C-UBT	Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group	6 weeks
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing	Analyze and compare the early and long-term changes of intestinal flora before and after eradication. Explore the effect of fucoidan on intestinal flora of patients receiving eradication treatment.	6 weeks

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Fucoidan; Amoxicillin; Helicobacter Pylori Infection; Eradication treatment; vonoprazan; Intestinal flora
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Anti-Infective Agents; Antineoplastic Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Anticoagulants; Anti-Ulcer Agents; Amoxicillin; Fucoidan
• Other Study ID Numbers: KY20220518-02-KS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No