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Novel Breath Test To Detect Early Stage Chronic Pancreatitis

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43DK089787-01
Agency Tracking Number: DK089787
Amount: $102,265.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDDK
Solicitation Number: PHS2010-2
Solicitation Year: 2010
Award Year: 2010
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
DUNS: 615111598
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (603) 598-6960
Business Contact
Phone: (603) 598-6960
Research Institution
DESCRIPTION (provided by applicant): Disorders of the pancreas affect more than one million persons in this country with nearly 3 billion in health care costs. The incidence rate of chronic pancreatitis (CP) is rapidly increasing and may be related to expanded alcohol abuse. Advanced CP causes severe structural damage to the pancreas leading to chronic abdominal pain, endocrine failure (diabetes mellitus) and exocrine failure (fat malabsorption). Advanced CP can be easily detected by imaging techniques such as CT scans, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound. However, mild to moderate CP presents a more difficult challenge for the clinician. Imaging techniques fail to recognize less advanced CP cases about 40% of the time. A more sensitive test to detect mild to moderate CP is the secretin stimulation test. But this test is invasive requiring a patient to swallow an intestinal tube which is placed in the duodenum and checked under fluoroscopic evaluation. The secretin stimulation test is only done in a few US centers, exposes the patient to radiation, and requires tube placement and collection of pancreatic secretions without sedation for one hour which causes patient discomfort. We have developed a new, non-invasive, non-radioactive 13C breath test named the Pancreatic Breath Test (PBT). This breath test uses a tracer dose of sodium 13C-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreas by secretin. A normal pancreas will release unlabeled bicarbonate upon stimulation, decreasing the ratio of 13C/12C of exhaled carbon dioxide. Smaller changes in the ratio of 13C/12C of exhaled carbon dioxide are expected with chronic pancreatitis. We developed the test based on the basic principle of the secretin stimulation test which detects early changes in bicarbonate exocrine function. A case-control study in 25 mild to moderate CP patients and 25 healthy controls will be utilized to show feasibility of the new breath test. It is our hypothesis that measuring the loss of bicarbonate released by the pancreas will be beneficial to detecting early stage CP. Such an accurate diagnosis early on will lead to an improved quality of life and a decreased number of expensive and invasive procedures resulting in decreased health care costs. Effective treatment of a CP patient begins with a reliable diagnosis. The long-term outlook of mild to moderate CP can be improved with pancreatic enzyme therapy when CP is detected at an early stage. Since breath testing is currently a routine procedure in many reference laboratories, the PBT can be utilized as a relatively cheap ( 100) send-out test which could be administered at local health centers. PUBLIC HEALTH RELEVANCE: Diagnosis of early-stage chronic pancreatitis is one of the greatest challenges in gastroenterology. We will develop a non-invasive breath test that is low-cost with high sensitivity for detecting early-stage chronic pancreatitis. The net result is an improvement in the quality of care and an overall reduction in health care costs associated with identifying chronic pancreatic disease.

* Information listed above is at the time of submission. *

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