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Clinical Trial Summary

Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Celiac Disease
  • Diarrhea
  • Exocrine Pancreatic Insufficiency
  • Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
  • Patients With Pancreatic Exocrine Insufficiency

NCT number NCT01865695
Study type Interventional
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact
Status Terminated
Phase Phase 4
Start date May 2013
Completion date August 2014