Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
Condition: Diarrhea; Exocrine Pancreatic Insufficiency; Abdominal Pain
MeSH terms: Exocrine Pancreatic Insufficiency; Diarrhea; Abdominal Pain
Study type: Observational

Summary: 
      The prevalence of exocrine pancreatic insufficiency (EPI) among patients presenting with
      diarrhea and bloating as their chief complaints is not well studied. Diarrhea and or bloating
      can be due to different etiologies such as celiac disease and irritable bowel syndrome.
      However, concomitant EPI can exacerbate these conditions, or be the main cause of the
      symptoms. Furthermore, some of these diagnoses can be epiphenomena or consequences of EPI.
      The Investigators hypothesize that EPI will be detected in significant proportion of patients
      with bloating or diarrhea and that early detection and management of EPI can prevent
      unnecessary work up for other causes of diarrhea.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Population ages 18-80 will be recruited from St. Luke Baylor's Clinic during their
        clinic visit. Patients will receive full complete details about the research protocol and
        then will receive a consent form with all steps taken in details for the research.
        Participating in this research will be voluntary and if the patient decides to participate
        in the research they will need to sign and date the consent form. Patients to be recruited
        during the clinic visits are patients of the PI and/or of the Co-Investigators in this
        study.
      
Keywords: Exocrine; Pancreatic Insufficiency; Diarrhea; Bloating; Loose Stool