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

Phase 2

Completed

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

• Registration Number: NCT01259544
• Lead Sponsor: Meridian Bioscience, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2010-12-12
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Di -petide breath tests and ePFT secretin induced	benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)	Di peptide breath tests will be performed on subjects with known chronic pancreatitis
c13 di peptide breath tests	benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)	Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Asian Institute of Gastroenterology, Hyderabad, India; 🇮🇳 Somajiguda, Hyderabad, India