NCT07142798

Brief Summary

To assess the efficacy and safety of 14-day bismuth/amoxicillin/PCAB triple therapy for the treatment of Helicobacter pylori infection in Taiwan

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 19, 2025

Last Update Submit

August 25, 2025

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori therapy

Outcome Measures

Primary Outcomes (1)

  • Eradicaton rate of Helicobacter pylori

    13CUBT

    6 weeks after finishing study drugs

Secondary Outcomes (1)

  • evaluate side effect

    2days after taking medicine

Study Arms (1)

Helicbpacyer pylori infection

EXPERIMENTAL

Helicbpacyer pylori infection

Drug: Bismuth amoxilillin potassium

Interventions

Bismuth amoxilillin potassiumDRUG

vonoprazan 20mg， Twice a day amoxicillin 750mg，Four times a day tripotassium dicitrate bismuthate 300mg，Four times a day for 14 days

Helicbpacyer pylori infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects infected with Helicobacter pylori.

You may not qualify if:

  • Those who are allergic to the drugs used in this research.
  • Those who have had stomach surgery.
  • Those with severe liver cirrhosis or uremia or malignant tumors.
  • Women who are pregnant or breastfeeding. If you have drug allergies or pregnant women or breast-feeding women during the test period, you can withdraw from the test early.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 27, 2025

Study Start

September 26, 2024

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)