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Trial record 23 of 457 for:    "hereditary pancreatitis" OR "Pancreatitis, Chronic" OR "Pancreatitis"

Novel Breath Test to Detect Early Stage Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01184573
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : February 10, 2014
University of Florida
Information provided by (Responsible Party):
Metabolic Solutions Inc.

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
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.

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Study Type : Observational
Estimated 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 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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.

Primary Outcome Measures :
  1. Output of C13-CO2 [ Time Frame: 15 minutes ]
    Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes

Biospecimen Retention:   Samples Without DNA
Breath samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01184573

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Metabolic Solutions Inc.
University of Florida
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Principal Investigator: Phillip P Toskes, MD University of Florida at Gainesville
Principal Investigator: David A Wagner, PhD Metabolic Solutions Inc.

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Responsible Party: Metabolic Solutions Inc. Identifier: NCT01184573     History of Changes
Other Study ID Numbers: PBT01
1R43DK089787-01 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014
Keywords provided by Metabolic Solutions Inc.:
chronic pancreatitis
breath test
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases