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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259544
• Other study ID #: CP-EX-110
• Status: Completed
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Healthy Volunteers
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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
• 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.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology, Hyderabad, India	Somajiguda	Hyderabad

Sponsors (3)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.	Asian Institute of Gastroenterology, Hyderabad, India, Virginia Commonwealth University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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