Fucoidan Assisted Eradication of Helicobacter Pylori

NCT ID: NCT05461508

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-07-31

Brief 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

Keywords

Helicobacter Pylori Infection; Eradication treatment; Amoxicillin; vonoprazan; Fucoidan; Intestinal flora

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Amoxicillin combined with vonoprazan

Intervention Type: OTHER

Amoxicillin and vonoprazan were used as the study control group

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.

Group Type: EXPERIMENTAL

Amoxicillin combined with vonoprazan and fucoidan

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Amoxicillin combined with vonoprazan

Amoxicillin and vonoprazan were used as the study control group

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Zhang

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhenyu Zhang, Master

Role: primary

Wenjuan Wei, Doctor

Role: backup

Other Identifiers

KY20220518-02-KS-01

Identifier Type: -

Identifier Source: org_study_id