Novel Breath Test to Detect Early Stage Chronic Pancreatitis

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.

Inclusion Criteria:

- 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 Criteria:

- 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.