NCT04029493

Brief Summary

The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.

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
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

July 21, 2019

Last Update Submit

July 21, 2019

Conditions

Keywords

Re-infection

Outcome Measures

Primary Outcomes (1)

  • The rate of re-infection

    The rate of re-infection will be described by the frequency and percentage.

    4 years

Secondary Outcomes (1)

  • The influence factors of the rate of re-infection

    4 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients in Shandong province, aged between 18 and 70 years old, with previous positive H. pylori infection that suceessed to be eradicated by therapies are included.

You may qualify if:

  • Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

You may not qualify if:

  • Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 257000, China

RECRUITING

MeSH Terms

Conditions

Reinfection

Condition Hierarchy (Ancestors)

RecurrenceDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiuli Zuo, MD,PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR
  • Tian Ma, MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

July 21, 2019

First Posted

July 23, 2019

Study Start

September 1, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations