NCT02933229

Brief Summary

Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
66mo left

Started Oct 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress64%
Oct 2016Oct 2031

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

15 years

First QC Date

October 11, 2016

Last Update Submit

October 12, 2016

Conditions

Helicobacter Pylorithe Operative Link on Gastric Intestinal MetaplasiaOperative Link on Gastric Intestinal Assessment

Outcome Measures

Primary Outcomes (3)

  • The proportion of more severe inflammation in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status

    15 years

  • The proportion of more severe atrophy in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status

    15 years

  • The proportion of more severe IM in the gastric mucosa for 15 years after H. pylori eradication at five points of the stomach compared with original status

    15 years

Secondary Outcomes (2)

  • The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link on gastritis assessment (OLGA) system compared with original status.

    15 years

  • The proportion of more advanced stages for 15 years after H. pylori eradication by using operative link for gastritis intestinal metaplasia (OLGIM) system compared with original status.

    15 years

Study Arms (1)

H. pylori eradication cohort

EXPERIMENTAL

H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin. If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication.

Device: biopsyDrug: H. pylori eradication

Interventions

biopsyDEVICE

patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.

H. pylori eradication cohort
H. pylori eradicationDRUG

H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin. If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication.

H. pylori eradication cohort

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with H. pylori infection;
  • Aged 18-65 years.

You may not qualify if:

  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
  • Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
  • Pregnancy or breastfeeding;
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Li Yanqing, MD, PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)