Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Phase 4

Terminated

• Conditions: Patients With Pancreatic Exocrine Insufficiency; Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
• Interventions: Other: Placebo; Drug: Creon

• Registration Number: NCT01865695
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.
Creon	Creon	Active treatment will be 2 capsules of Creon 25,000 units three times per day and the placebo will be 2 capsules three times per day; for 6 weeks treatment overall.

Primary Outcome Measures

Name	Time	Method
Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment	6 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 weeks	Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment
body mass index	6 weeks	body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

Trial Locations

Locations (1)

Department of Gastroenterology; 🇬🇧 Sheffield, South Yorkshire, United Kingdom