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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259544
First Posted: December 14, 2010
Last Update Posted: February 16, 2012
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.
Collaborators:
Virginia Commonwealth University
Asian Institute of Gastroenterology, Hyderabad, India
Information provided by:
Exalenz Bioscience LTD.
  Purpose
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.

Condition Intervention Phase
Chronic Pancreatitis Healthy Volunteers Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • 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). [ Time Frame: 1 hour ]
    This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.


Secondary Outcome Measures:
  • To assess the ability to differentiate between non patients with chronic pancreatitis and those without. [ Time Frame: 1 hour ]
    In order to establish the efficacy of this test, it is necessary to confirm that a difference is observed between healthy and non- healthy subjects


Enrollment: 33
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Di -petide breath tests and ePFT secretin induced
Di peptide breath tests will be performed on subjects with known chronic pancreatitis
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
Active Comparator: c13 di peptide breath tests
Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis
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.

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
  3. Patients who can fast for at least 8 hours
  4. Able to perform the testing and procedures required for the study, as judged by the investigator
  5. 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01259544


Locations
India
Asian Institute of Gastroenterology, Hyderabad, India
Somajiguda, Hyderabad, India, 500 082
Sponsors and Collaborators
Exalenz Bioscience LTD.
Virginia Commonwealth University
Asian Institute of Gastroenterology, Hyderabad, India
  More Information

Responsible Party: Bimaljit S Sandhu, M.D, Virginia Commonwealth University Medical Center
ClinicalTrials.gov Identifier: NCT01259544     History of Changes
Other Study ID Numbers: CP-EX-110
First Submitted: December 12, 2010
First Posted: December 14, 2010
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by Exalenz Bioscience LTD.:
CP-Chronic Pancreatitis
DPT-Di peptide breath test
ePFT- Endoscopic pancreatic function test

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