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

NCT01259544 | Completed Phase 2 DMC

• 1 other identifier: CP-EX-110
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pancreatitis; Healthy Volunteers

Keywords

CP-Chronic Pancreatitis; DPT-Di peptide breath test; ePFT- Endoscopic pancreatic function test

Outcome Measures

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).

  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.

  1 hour

Secondary Outcomes (1)

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

  1 hour

Study Arms (2)

Di -petide breath tests and ePFT secretin induced

ACTIVE COMPARATOR

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

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

c13 di peptide breath tests

ACTIVE COMPARATOR

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

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

Interventions

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

Di -petide breath tests and ePFT secretin induced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead
• Virginia Commonwealth University: collaborator
• Asian Institute of Gastroenterology, Hyderabad, India: collaborator

Study Sites (1)

Asian Institute of Gastroenterology, Hyderabad, India

Somājigūda, Hyderabad, 500 082, India

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

benzoyl-tyrosyl-alanine

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

IN (1)