BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
NCT ID: NCT01259544
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2009-01-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Di -petide breath tests and ePFT secretin induced
Di peptide breath tests will be performed on subjects with known chronic pancreatitis
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
300 mg of powder form dissolved in one cup of tap water prior to breath test
c13 di peptide breath tests
Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.
Interventions
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benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
300 mg of powder form dissolved in one cup of tap water prior to breath test
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
Yes
Sponsors
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Virginia Commonwealth University
OTHER
Asian Institute of Gastroenterology, Hyderabad, India
UNKNOWN
Meridian Bioscience, Inc.
INDUSTRY
Responsible Party
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Virginia Commonwealth University Medical Center
Locations
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Asian Institute of Gastroenterology, Hyderabad, India
Somājigūda, Hyderabad, India
Countries
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Other Identifiers
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CP-EX-110
Identifier Type: -
Identifier Source: org_study_id