search
Back to results

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

Primary Purpose

Chronic Pancreatitis, Healthy Volunteers

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
Sponsored by
Meridian Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Pancreatitis focused on measuring CP-Chronic Pancreatitis, DPT-Di peptide breath test, ePFT- Endoscopic pancreatic function test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Asian Institute of Gastroenterology, Hyderabad, India

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Di -petide breath tests and ePFT secretin induced

c13 di peptide breath tests

Arm Description

Di peptide breath tests will be performed on subjects with known chronic pancreatitis

Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis

Outcomes

Primary Outcome Measures

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).
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 Outcome Measures

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

Full Information

First Posted
December 12, 2010
Last Updated
December 19, 2022
Sponsor
Meridian Bioscience, Inc.
Collaborators
Virginia Commonwealth University, Asian Institute of Gastroenterology, Hyderabad, India
search

1. Study Identification

Unique Protocol Identification Number
NCT01259544
Brief Title
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meridian Bioscience, Inc.
Collaborators
Virginia Commonwealth University, Asian Institute of Gastroenterology, Hyderabad, India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Healthy Volunteers
Keywords
CP-Chronic Pancreatitis, DPT-Di peptide breath test, ePFT- Endoscopic pancreatic function test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Di -petide breath tests and ePFT secretin induced
Arm Type
Active Comparator
Arm Description
Di peptide breath tests will be performed on subjects with known chronic pancreatitis
Arm Title
c13 di peptide breath tests
Arm Type
Active Comparator
Arm Description
Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis
Intervention Type
Drug
Intervention Name(s)
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
Intervention Description
300 mg of powder form dissolved in one cup of tap water prior to breath test
Intervention Type
Drug
Intervention Name(s)
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
Intervention Description
300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
To assess the ability to differentiate between non patients with chronic pancreatitis and those without.
Description
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
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Asian Institute of Gastroenterology, Hyderabad, India
City
Somajiguda
State/Province
Hyderabad
ZIP/Postal Code
500 082
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs