Back to resultsFucoidan Assisted Eradication of Helicobacter Pylori
Primary Purpose
Helicobacter Pylori Infection, Intestinal Bacteria Flora Disturbance
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Amoxicillin combined with vonoprazan and fucoidan
Amoxicillin combined with vonoprazan
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori Infection, Eradication treatment, Amoxicillin, vonoprazan, Fucoidan, Intestinal flora
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old;
- Patients diagnosed as HP positive;
- 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;
- Voluntarily participate in this trial and sign the informed consent form.
Exclusion Criteria:
- Allergic to the study drug (penicillin allergy, etc.);
- Patients with chronic gastritis and peptic ulcer;
- Patients who have received HP eradication treatment within half a year;
- 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;
- Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
- History of esophageal or gastric surgery;
- Pregnant and lactating women;
- Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
Sites / Locations
- Nanjing First Hospital, Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Amoxicillin combined with vonoprazan
Amoxicillin combined with vonoprazan and fucoidan
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05461508
First Posted
July 11, 2022
Last Updated
February 8, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05461508
Brief Title
Fucoidan Assisted Eradication of Helicobacter Pylori
Official Title
Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Intestinal Bacteria Flora Disturbance
Keywords
Helicobacter Pylori Infection, Eradication treatment, Amoxicillin, vonoprazan, Fucoidan, Intestinal flora
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin combined with vonoprazan
Arm Type
Active Comparator
Arm Description
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
Arm Title
Amoxicillin combined with vonoprazan and fucoidan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Amoxicillin combined with vonoprazan and fucoidan
Intervention Description
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
Other
Intervention Name(s)
Amoxicillin combined with vonoprazan
Intervention Description
Amoxicillin and vonoprazan were used as the study control group
Primary Outcome Measure Information:
Title
compare eradication rates of the two groups by 13C-UBT
Description
Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group
Time Frame
6 weeks
Title
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years old;
Patients diagnosed as HP positive;
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;
Voluntarily participate in this trial and sign the informed consent form.
Exclusion Criteria:
Allergic to the study drug (penicillin allergy, etc.);
Patients with chronic gastritis and peptic ulcer;
Patients who have received HP eradication treatment within half a year;
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;
Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
History of esophageal or gastric surgery;
Pregnant and lactating women;
Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang, Master
Phone
+8618951670222
Email
zzy6565@sina.com
First Name & Middle Initial & Last Name & Degree
Wenjuan Wei, Doctor
Phone
+8618851009006
Email
wjwei.hf@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Fucoidan Assisted Eradication of Helicobacter Pylori
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