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

Meridian Bioscience

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteers; Chronic Pancreatitis

Treatments: Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01259544

CP-EX-110

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

33 participants in 2 patient groups

Di -petide breath tests and ePFT secretin induced

Active Comparator group

Description:

Di peptide breath tests will be performed on subjects with known chronic pancreatitis

Treatment:

Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

c13 di peptide breath tests

Active Comparator group

Description:

Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis

Treatment:

Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)