Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks), Patients With Pancreatic Exocrine Insufficiency
Conditions
Keywords
pancreatic exocrine insufficiency, faecal elastase, diarrhoea, coeliac, creon, gastrointestinal
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.
Interventions
DRUGCreon
Creon is a licensed product, manufactured by Abbott Laboratories, Inc. used for the therapeutic indication of pancreatic exocrine insufficiency. The route of administration is oral, with capsules being taken with main meals without chewing. The most commonly reported adverse reactions to Creon are gastrointestinal disorders of mild or moderate severity (up to 10% of patients). These include nausea, vomiting, constipation, diarrhoea and abdominal distension. An uncommon reaction (\<0.01%) of patients may develop skin reactions such as a rash or itching. No additional adverse drug reactions have been identified.
OTHERPlacebo
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed