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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Exalenz Bioscience LTD.
• Collaborators: Asian Institute of Gastroenterology, Hyderabad, India; Virginia Commonwealth University

Criteria

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