Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01865695
• Other study ID #: STH16190
• Status: Terminated
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Creon
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.

Other:
• Placebo

Locations

Country	Name	City	State
United Kingdom	Department of Gastroenterology	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment		6 weeks
Secondary	Quality of life	Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment	6 weeks
Secondary	body mass index	body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment	6 weeks