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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
| Asian Institute of Gastroenterology, Hyderabad, India | UNKNOWN |
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13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Di -petide breath tests and ePFT secretin induced | Active Comparator | Di peptide breath tests will be performed on subjects with known chronic pancreatitis |
|
| c13 di peptide breath tests | Active Comparator | Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
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Inclusion Criteria:
Patients with chronic pancreatitis who meet at least one of the following criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology, Hyderabad, India | Somājigūda | Hyderabad | 500 082 | India |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C526135 | benzoyl-tyrosyl-alanine |
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| benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) | Drug | 300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |