NCT00194688

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

January 11, 2008

Status Verified

January 1, 2008

First QC Date

September 13, 2005

Last Update Submit

January 2, 2008

Conditions

Helicobacter Infections

Keywords

ammonia

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of breath ammonia measurement for H. pylori infection

Secondary Outcomes (2)

  • 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.

Interventions

H. pylori treatmentDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • David L Putnam, PhD

    Pacific Technologies, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

March 1, 2003

Study Completion

June 1, 2005

Last Updated

January 11, 2008

Record last verified: 2008-01

Locations

US(1)