Status:
COMPLETED
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Virginia Commonwealth University
Asian Institute of Gastroenterology, Hyderabad, India
Conditions:
Chronic Pancreatitis
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 stimula...
Eligibility Criteria
Inclusion
- 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
- Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
- Patients who can fast for at least 8 hours
- Able to perform the testing and procedures required for the study, as judged by the investigator
- Willing and able to provide written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01259544
Start Date
January 1 2009
End Date
March 1 2009
Last Update
December 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asian Institute of Gastroenterology, Hyderabad, India
Somājigūda, Hyderabad, India, 500 082