NCT01278901

Brief Summary

STUDY PROTOCOL: The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons. The patients should not be on PPI therapy . If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy (ulcers or esophagitis), the investigators will repeat the gastroscopy within a month. During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure. If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present. After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become negative in the second endoscopy is considered false negative.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

First Submitted

Initial submission to the registry

January 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 16, 2011

Last Update Submit

January 18, 2011

Conditions

Helicobacter Pylori

Keywords

helicobacter pyloriurease test13C-UBTthe focus of the study is to evaluate a possible effect of PPI therapy on Helicobacter pylori diagnostic tests

Outcome Measures

Primary Outcomes (1)

  • Effect of PPI treatment on helicobacter pylori diagnostic tests

    1 month of therapy

Study Arms (1)

Cohort of consecutive patients undergoing EGD treated with PPI

Patients positive for helicobacter pylori undergoing EGD, started on PPI therapy for a month, repeated diagnostic tests for Helicobacter pylori after a month of therapy (urease test, histology and breath test)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI

You may qualify if:

  • Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI-

You may not qualify if:

  • Patients younger than 18 years and older than 80 years
  • Severe background diseases
  • Previous eradicated helicobacter pylori infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Central Study Contacts

Vered Shabat, MD

CONTACT

972-3-9732798veredsh3@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2011

First Posted

January 19, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

IL(1)