NCT05461508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

July 11, 2022

Last Update Submit

December 6, 2023

Conditions

Helicobacter Pylori InfectionIntestinal Bacteria Flora Disturbance

Keywords

Helicobacter Pylori InfectionEradication treatmentAmoxicillinvonoprazanFucoidanIntestinal flora

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Amoxicillin combined with vonoprazan

ACTIVE COMPARATOR

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 combined with vonoprazan and fucoidan

EXPERIMENTAL

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

Interventions

Amoxicillin combined with vonoprazan and fucoidanBIOLOGICAL

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.

Amoxicillin combined with vonoprazan and fucoidan
Amoxicillin combined with vonoprazanOTHER

Amoxicillin and vonoprazan were used as the study control group

Amoxicillin combined with vonoprazan

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanaminefucoidan

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 18, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2024

Study Completion

July 31, 2024

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations

CN(1)