Novel Breath Test to Detect Early Stage Chronic Pancreatitis

Phase 1 Study of the Pancreatic Breath Test to Detect Early Stage Chronic Pancreatitis Utilizing the Secretin Stimulation Test

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two study population groups. The case group will have evidence of mild to moderate chronic pancreatitis. The control group will be healthy without evidence of chronic disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Output of C13-CO2	Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes	15 minutes

Collaborators and Investigators

• Sponsor: Metabolic Solutions Inc.
• Collaborators: University of Florida
• Investigators: Principal Investigator: Phillip P Toskes, MD, University of Florida at Gainesville

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): February 10, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: chronic pancreatitis; breath test; bicarbonate
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: PBT01; 1R43DK089787-01 (U.S. NIH Grant/Contract)