Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase

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

Intervention / Treatment
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* Drug: Creon
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br> <br> |
| Active Comparator: Creon<br>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. | Drug: Creon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment | 6 weeks | 
| body mass index | body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic exocrine insufficiency, faecal elastase, diarrhoea, coeliac, creon, gastrointestinal