Fucoidan Assisted Eradication of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461508
• Other study ID #: KY20220518-02-KS-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections
• Intestinal Bacteria Flora Disturbance

Intervention

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

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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