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

NCT01259544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-12-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER
  • Asian Institute of Gastroenterology, Hyderabad, India

    collaborator UNKNOWN
  • Meridian Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259544 on ClinicalTrials.gov