- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03407534
Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
Early Detection of Exocrine Pancreatic Insufficiency in Patients Presenting With Diarrhea and Bloating
Study Overview
Status
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 to 80 years old who presents to the gastroenterology clinic with main complaints of diarrhea
- Patients aged 18-80 years old who presents to the gastroenterology clinic with main complaints of flatulence, and/or bloating
- Patients with known IBS, microscopic colitis or celiac disease diagnosis will be included.
- Patients on Diphenxoylate, loperamide or cholestyramin will be included.
Exclusion Criteria:
- Known chronic pancreatitis, recurrent acute pancreatitis or autoimmune pancreatitis.
- Known Pancreatic cancer
- Prior History of distal pancreatictomy or Whipple surgery.
- Prior history of gastric bypass surgery or any Roux en Y gastrojeujunal anastomosis.
- Pregnant Patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4-6 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Othman, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-37932
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Pain
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedFunctional Gastrointestinal Disorders | Functional Abdominal Pain Syndrome | Abdominal Pain (AP)
-
Duke UniversityUnknown
-
Children's Mercy Hospital Kansas CityUniversity of ArizonaCompletedFunctional Abdominal Pain
-
University of WashingtonUniversity of North Carolina; MultiCare Mary Bridge Children's Hospital & Health...Completed
-
University of MichiganTerminatedFunctional Abdominal PainUnited States
-
University of BariClinica PEdiatrica Ospedale San Paolo Bari ItalyCompletedFunctional Abdominal PainItaly
-
National Center for Complementary and Integrative...CompletedRecurrent Abdominal PainUnited States
-
Jacques E. ChellyNational Institute on Drug Abuse (NIDA); Masimo CorporationRecruitingOpioid Use | Cancer Pain | Auriculotherapy | Pain, AbdominalUnited States
-
Michigan State UniversitySpectrum Health HospitalsWithdrawnFunctional Abdominal Pain SyndromeUnited States
-
Region Örebro CountyÖrebro University, SwedenActive, not recruitingFunctional Abdominal Pain | IBSSweden