Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03407534|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|Condition or disease|
|Diarrhea Exocrine Pancreatic Insufficiency Abdominal Pain|
Exocrine pancreatic insufficiency (EPI) diagnosis can be challenging due to several reasons. First, the main symptoms of EPI such as diarrhea, loose stool, bloating or weight loss have low specificity because they could be associated with many other conditions such as IBS or celiac disease. Second, EPI could be found concomitantly as an exacerbating factor with other causes of diarrhea and bloating leading to incomplete treatment and increased patient dissatisfaction due to partial resolution of symptoms. Although the prevalence of EPI in general population is not well known, a recent population study in 914 patients from Norway showed up to 10% prevalence of EPI using the measurement of fecal elastase-1 level in elderly. In another study, the prevalence of EPI diagnosed by low fecal elastase-1 in 314 patients with chronic diarrhea who satisfied the Rome II criteria for irritable bowel syndrome diarrhea (IBS-D) was 6.1%.Furthermore, an EPI prevalence of 4.4% (diagnosed by low fecal elastase-1) was documented in 90 patients who had serological and histological evidence of celiac disease. Interestingly, MRI was normal in all patients diagnosed with EPI in this study.
The gold standard tests for diagnosing EPI is three-day fecal fat quantification and determination of the coefficient of fat absorption. The patient is required to keep an intake of 100g of fat for five days and then collect feces for a time period of three days. Direct measurement of pancreatic function test with secreting stimulation is another sensitive test. . However these tests are cumbersome to apply to large number of patients with common complaints. Spot fecal elastase-1 measurement using enzyme linked immunosorbent assay (ELISA) has been shown to be highly sensitive and specific in diagnosing moderate to severe chronic pancreatitis in several studies. The favorable operating characteristics combined with the ease of using of the test makes it a good initial screening test for EPI.
Our preliminary data indicate that a large proportion (10 %) of patients with undiagnosed bloating and or diarrhea have EPI initially detected by low fecal elastase-1 and subsequently confirmed with Endoscopic Ultrasound and or direct measurement of pancreatic function tests. Therefore, Investigators propose to test the hypothesis that including fecal elastase-1 as part of the initial work-up for patients presenting with diarrhea and or bloating will identify patients who are confirmed EPI and may benefit from pancreatic enzyme replacement therapy and limit further unnecessary work up.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Early Detection of Exocrine Pancreatic Insufficiency in Patients Presenting With Diarrhea and Bloating|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
- Prevelance of Pancreatic Insufficency among patients that complain of symptoms of diarrhea and bloating [ Time Frame: 4-6 Weeks ]1- Estimate the prevalence of the spectrum of EPI among patients presenting with diarrhea and bloating as chief complaints using fecal elastase-1 levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407534
|Contact: Mohamed O. Othman, MD||713-798-0950||Mohamed.Othman@bcm.edu|
|Contact: Maha Husainatemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mohamed Othman, MD 713-798-0950 Mohamed.Othman@bcm.edu|
|Principal Investigator:||Mohamed Othman, MD||Baylor College of Medicine|