NCT01259544

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pancreatitis
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	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
DRUG	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2010-12-14
• Last updated: 2022-12-20

Locations

1 site across 1 country: India