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

This study has been completed.
Sponsor:
Collaborators:
Virginia Commonwealth University
Asian Institute of Gastroenterology, Hyderabad, India
Information provided by:
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT01259544
First received: December 12, 2010
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Alanine
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 12, 2010
Last Updated: February 15, 2012
Health Authority: India Ministry of Health, India:

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
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013