Novel Breath Test to Detect Early Stage Chronic Pancreatitis

NCT01184573 | Completed DMC

• 2 other identifiers: PBT011R43DK089787-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; breath test; bicarbonate

Outcome Measures

Primary Outcomes (1)

• Output of C13-CO2

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

  15 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabolic Solutions Inc.: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath samples

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillip P Toskes, MD

  University of Florida at Gainesville

  PRINCIPAL INVESTIGATOR

• David A Wagner, PhD

  Metabolic Solutions Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

US (1)