Trial | NCT01259544  Report issue

Title

BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.
Study Started
Jan 31
2009
Primary Completion
Feb 28
2009
Study Completion
Mar 31
2009
Last Update
Dec 20
2022

Drug benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

300 mg of powder form dissolved in one cup of tap water prior to breath test

Drug benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.

Di -petide breath tests and ePFT secretin induced Active Comparator

Di peptide breath tests will be performed on subjects with known chronic pancreatitis

c13 di peptide breath tests Active Comparator

Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis

Criteria 

Inclusion Criteria:

Patients with chronic pancreatitis who meet at least one of the following criteria:

Adult men or women >18 years of age.
Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
Abnormal secretin pancreatic function test with a peak bicarbonate concentration <80 mEq/L
Presence of pathogenomic pancreatic calcifications
Pathology proven chronic pancreatitis on surgical specimens
Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
Patients who can fast for at least 8 hours
Able to perform the testing and procedures required for the study, as judged by the investigator
Willing and able to provide written informed consent

Exclusion Criteria:

Failure to obtain consent
Patients with liver cirrhosis
Any co-morbid condition with expected survival < 1 year
History of extensive bowel resection, multiple abdominal surgeries
Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
Uncontrolled diabetes
Patients currently receiving total parenteral nutrition (TPN)
Recipients of an organ transplant
Patients who have consumed >20cc of alcohol or have taken acetaminophen in the past 24 hours
History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
Patients taking drugs that can interfere with 13C di-peptide metabolization
No Results Posted