The Effect of PPI Therapy on the Result of Helicobacter P... | NCT01278901

Studies
The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests

NCT01278901

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jan 19, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Helicobacter Pylori

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2012Estimated

Completion Date

Not provided

First Submitted Date

Jan 16, 2011

First Submission Date that Met QC Criteria

Jan 18, 2011

First Posted Date

Jan 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of PPI treatment on helicobacter pylori diagnostic tests		1 month of therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vered Shabat, MD	Contact	972-3-9732798	2798	veredsh3@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Rabin Medical Center		Petah Tikva		49100	Israel