Novel Breath Test to Detect Early Stage Chronic Pancreatitis
Completed
Conditions studied: Chronic Pancreatitis
In brief
The goal of this study is to evaluate the feasibility of using a non-invasive, non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of chronic pancreatitis (CP). If successful, this method could have important advantages over existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have a clinical impact if it leads to early detection of CP and intervention to mitigate disease progression.
Key facts
- Study ID
- NCT01184573
- Run by
- Metabolic Solutions Inc.
- People needed
- 50
- Starts
- 2011-05-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2014-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male of female greater than or equal to 18 years of age.
- Subjects must have the ability to give informed consent.
- Female subjects of child bearing potential must use a medically acceptable form of birth control and have a negative pregnancy test.
- For case subjects with mild to moderate chronic pancreatitis, they must have either an abnormal endoscopic ultrasound (greater than 4 abnormalities), an abnormal secretin stimulation test, an abnormal endoscopic retrograde cholangiopancreatography (ERCP), an abnormal CT scan of the pancreas (dilation of the main pancreatic duct or atrophy of the pancreas), a serum trypsin level <29 ng/ml but >20 ng/ml, or a fecal elastase of less than 200 mcg/gram stool but greater than 100 mcg/gram stool.
You may not qualify if…
- Females who are lactating or pregnant.
- Subjects with acute pancreatitis.
- Subjects known to have a significant medical and/or mental disease.
- Subjects receiving an investigational new drug within 30 days.
- Subjects on enzyme therapy, proton pump inhibitors, H2 receptor antagonists.
- Subjects who have had a recent febrile illness within 5 days of scheduled entry into the study. Body temperature must be normal for at least 72 hours before entering the study.
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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