Breath Ammonia Method for H. Pylori Detection: Phase II | NCT00194688

Studies
Breath Ammonia Method for H. Pylori Detection: Phase II

NCT00194688

Sponsor

University of Washington

Status

Completed

Last Update Posted

Jan 11, 2008Estimated

Enrollment

278

Phase

Phase 2

Conditions

Helicobacter Infections

Interventions

H. pylori treatment

Countries

United States

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

ID	Type	Description	Link
2R44DK055935-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

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 2, 2008

Last Update Posted Date

Jan 11, 2008Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Description Module

Brief Summary

The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.

Detailed Description

Healthy volunteers will undergo testing for H. pylori infection using a 14-C urea breath test, and the results will be compared to an experimental ammonia breath test. The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube. To meet the Phase II specific aim, the scope of the clinical trials is expanded addressing the following specific objectives:

Test refinements of the sensing system (hardware, software, & breath test device)
Determine whether a urea dose-response effect exists following urea ingestion,
Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H. pylori infected vs. uninfected persons.
Determine the appropriate time interval for breath ammonia testing following urea ingestion.
Determine whether there is a change in breath ammonia level after H. pylori treatment.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278

Name	Type	Description	Arm Group Labels	Other Names
H. pylori treatment	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of breath ammonia measurement for H. pylori infection

Secondary Outcomes

Measure	Description	Time Frame
Determination of a dose response relationship for oral urea dose and breath ammonia level.
Determination of whether breath ammonia measurement allows determination of successful H. pylori treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult volunteers not meeting exclusion criteria

Exclusion Criteria:

Known cirrhosis of the liver
Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
Prior gastric resection
Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
Patients who have received antibiotics or bismuth within the preceding month.
Patients unwilling or unable to give informed consent
Pregnant women (14C urea breath test is not approved for use in pregnant women)
Age less than 21 years (14C urea breath test is not approved for use in children)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David L Putnam, PhD	Pacific Technologies, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Puget Sound Health Care System		Seattle	Washington	98108	United States

Condition Browse Module

MeSH Terms

ID	Term
D016481	Helicobacter Infections

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided