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Completed

NCT Number: NCT01259544

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

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

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Healthy Volunteers Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asian Institute of Gastroenterology, Hyderabad, India

Somājigūda, Hyderabad, 500 082, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

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

Drug

300 mg of powder form dissolved in one cup of tap water prior to breath test

Primary outcomes

  1. 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).

    Time frame: 1 hour

    This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.

Secondary outcomes

  1. To assess the ability to differentiate between non patients with chronic pancreatitis and those without.

    Time frame: 1 hour

    In order to establish the efficacy of this test, it is necessary to confirm that a difference is observed between healthy and non- healthy subjects

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Collaborators

  • Asian Institute of Gastroenterology, Hyderabad, India
  • Virginia Commonwealth University

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2010
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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