Current partner codePEPTIDESDE
NCT01259544·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

33

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Dec 14, 2010

  2. Study start

    Jan 2009

  3. Primary completion

    Feb 2009

  4. Study completion

    Mar 2009

  5. Results posted

    Not reported

  6. Registry updated

    Dec 20, 2022

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

India. Showing up to 24 locations stored in the fast local snapshot.

Asian Institute of Gastroenterology, Hyderabad, India

Somājigūda, Hyderabad, India

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.