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

13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Chronic Pancreatitis
• Intervention / Treatment: Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala); Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Hyderabad
    • Somajiguda, Hyderabad, India, 500 082
      • Asian institute of Gastroenterology, hyderabad, India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the ability to differentiate between non patients with chronic pancreatitis and those without.	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	1 hour

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Collaborators: Virginia Commonwealth University; Asian Institute of Gastroenterology, Hyderabad, India

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 12, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: CP-Chronic Pancreatitis; DPT-Di peptide breath test; ePFT- Endoscopic pancreatic function test
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: CP-EX-110