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Abstract
Grant Number: 5R44DK055935-03 PI Name: PUTNAM, DAVID L. PI Email: putnam@photonicsystems.com PI Title: Project Title: Breath Ammonia Method for H. pylori Detection Abstract: DESCRIPTION (provided by applicant): The project will develop a simple test for noninvasive diagnosis of active Helicobacter pylori infection in the stomach based on measuring ammonia in patients' breath. A novel highly sensitive optical technique will be used to measure breath ammonia, leading to an inexpensive diagnostic procedure that can be conducted in any general practitioner's office. An improved method of detecting gastric H. pylori is of clinical significance because the organism is the cause of most peptic ulcers and is associated with other gastrointestinal diseases including cancers. The new breath ammonia sensing method will be useful for diagnosis of infected patients, as well as for follow-up determinations of infectious status after therapy. Phase I results demonstrated 100 percent agreement with conventional 14C-labeled breath tests The research will optimize the clinical instrumentation, expand the scope of the Phase I clinical trial to a larger, more diverse patient set, and study test parameters that maximize the clinical diagnostic value of the test. This work will redisign the sensor and instrument as a logical and practical step to final product commercialization. Subsequent pre-market testing for commercialization will implement those instrument and test procedure and confirm their clinical efficacy.
Thesaurus Terms:
Helicobacter, ammonia, bacterial disease, biomedical equipment development, breath test, communicable disease diagnosis, diagnosis design /evaluation, fiber optics, gastrointestinal disorder diagnosis
gastrointestinal neoplasm, monitoring device, noninvasive diagnosis, peptic ulcer, urea, urease
clinical research, human subject, patient oriented research
Institution: PACIFIC TECHNOLOGIES 21806 NE 1ST REDMOND, WA 98053 Fiscal Year: 2003 Department: Project Start: 01-SEP-1999 Project End: 31-MAY-2004 ICD: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES IRG: ZRG1