Novel Breath Test to Detect Early Stage Chronic Pancreatitis
|ClinicalTrials.gov Identifier: NCT01184573|
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : February 10, 2014
|Condition or disease|
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 can be easily detected by imaging techniques. However, mild to moderate CP presents a more difficult challenge for clinicians. Imaging techniques fail to recognize less advanced CP cases about 40% of the time. The gold standard for monitoring early stage CP is the secretin stimulation test. However, the secretin stimulation test is only done in a few US centers.
The investigators have developed the Pancreatic Breath Test (PBT) as an alternative to the secretin stimulation test. The breath test uses a tracer dose of sodium 13C-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreatitis by a meal (liquid Ensure). A normal pancreas releases unlabeled bicarbonate upon stimulation, decreasing the ratio of 13C/12C of exhaled carbon dioxide. This ratio will change much less in a diseased pancreas.
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Phase 1 Study of the Pancreatic Breath Test to Detect Early Stage Chronic Pancreatitis Utilizing the Secretin Stimulation Test|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||September 2012|
Mild to Moderate CP
Subjects must have a history compatible with chronic pancreatitis.
Subjects must be in good health of greater than 18 years of age.
- Output of C13-CO2 [ Time Frame: 15 minutes ]Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184573
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Phillip P Toskes, MD||University of Florida at Gainesville|
|Principal Investigator:||David A Wagner, PhD||Metabolic Solutions Inc.|