Status:
TERMINATED
Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
Patients With Pancreatic Exocrine Insufficiency
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- patients with coeliac disease and having chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks)
- Patients with a low faecal elastase (\<200 ug/g),
- Patients aged 16 years or over
- Patient able to give written consent to participate
- Patient not currently on Creon
Exclusion
- Patients with normal faecal elastase (\> 201ug/g),
- Patients under the age of 16
- Patients allergic to pork or any pig product (advice from the drug manufacturer)
- Patients that are pregnant or are breast-feeding
- Patients taking alternative medication that could affect bowel frequency
- Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial
- Patients who are unable to speak or understand English
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01865695
Start Date
May 1 2013
End Date
August 1 2014
Last Update
September 23 2019
Active Locations (1)
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1
Department of Gastroenterology
Sheffield, South Yorkshire, United Kingdom, S10 2JF