Novel Breath Test to Detect Early Stage Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Metabolic Solutions Inc.
ClinicalTrials.gov Identifier:
NCT01184573
First received: August 17, 2010
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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
Chronic Pancreatitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Metabolic Solutions Inc.:

Primary Outcome Measures:
  • Output of C13-CO2 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes


Biospecimen Retention:   Samples Without DNA

Breath samples


Estimated Enrollment: 50
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184573

Locations
United States, Florida
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.
  More Information

No publications provided

Responsible Party: Metabolic Solutions Inc.
ClinicalTrials.gov Identifier: NCT01184573     History of Changes
Other Study ID Numbers: PBT01, 1R43DK089787-01
Study First Received: August 17, 2010
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Metabolic Solutions Inc.:
chronic pancreatitis
breath test
bicarbonate

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014