Novel Breath Test to Detect Early Stage Chronic Pancreatitis

Sponsor

Metabolic Solutions Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01184573

Collaborator

University of Florida (Other)

Enrollment

Location

16.1

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis

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 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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Mild to Moderate CP Subjects must have a history compatible with chronic pancreatitis.
Healthy Controls Subjects must be in good health of greater than 18 years of age.

Outcome Measures

Primary Outcome Measures

Output of C13-CO2 [15 minutes]
Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

Metabolic Solutions Inc.
University of Florida

Investigators

Principal Investigator: Phillip P Toskes, MD, University of Florida at Gainesville
Principal Investigator: David A Wagner, PhD, Metabolic Solutions Inc.