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

• Sponsor: Exalenz Bioscience LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01259544
• Collaborator: Virginia Commonwealth University (Other), Asian Institute of Gastroenterology, Hyderabad, India (Other)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 17

Study Details

Study Description

Brief Summary

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

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

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
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.

Outcome Measures

Primary Outcome Measures

1. 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). [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

1. To assess the ability to differentiate between non patients with chronic pancreatitis and those without. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)

2. Patients who can fast for at least 8 hours

3. Able to perform the testing and procedures required for the study, as judged by the investigator

4. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01259544
• Other Study ID Numbers: CP-EX-110
• First Posted: Dec 14, 2010
• Last Update Posted: Feb 16, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by , ,: CP-Chronic Pancreatitis; DPT-Di peptide breath test; ePFT- Endoscopic pancreatic function test
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Feb 16, 2012