Status:
COMPLETED
Novel Breath Test to Detect Early Stage Chronic Pancreatitis
Lead Sponsor:
Metabolic Solutions Inc.
Collaborating Sponsors:
University of Florida
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 ma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01184573
Start Date
May 1 2011
End Date
September 1 2012
Last Update
February 10 2014
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610