Clinical trial NCT01259544: BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pancreatitis
Healthy Volunteers
Keywords: CP-Chronic Pancreatitis
DPT-Di peptide breath test
ePFT- Endoscopic pancreatic function test
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Virginia Commonwealth University
name: Asian Institute of Gastroenterology, Hyderabad, India
First posted: 2010-12-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 1 hour
Secondary outcomes:
measure: To assess the ability to differentiate between non patients with chronic pancreatitis and those without.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Somajiguda
country: India
facility: Asian Institute of Gastroenterology, Hyderabad, India
state: Hyderabad
Study officials:
References: