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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creon | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Sanders, FRCP | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
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|
| Placebo | Other |
|
| 6 weeks |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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