Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

NHS Foundation Trust

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Creon; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01865695

STH16190

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Creon

Active Comparator group

Description:

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.

Treatment:

Drug: Creon