Expired Study
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Gainesville, Florida 32610


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

PBT01


NCT ID:

NCT01184573


Secondary ID:

1R43DK089787-01


Study Acronym:


Brief Title:

Novel Breath Test to Detect Early Stage Chronic Pancreatitis


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Metabolic Solutions Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Phillip P Toskes, MD
Principal Investigator
University of Florida at Gainesville

Study Dates

Start Date:May 2011
Completion Date:September 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 6, 2014
First Received Date:August 17, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Output of C13-CO2
Time Frame:15 minutes
Safety Issues:False
Description:Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Healthy Controls
Description:Subjects must be in good health of greater than 18 years of age.
Study Arm Type:Other
Arm Name:Mild to Moderate CP
Description:Subjects must have a history compatible with chronic pancreatitis.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Metabolic Solutions Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Florida

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Breath samples
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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