Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

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

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.

Study Overview

• Status: Terminated
• Conditions: 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: Other: Placebo; Drug: Creon

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Department of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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
Active Comparator: Creon; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: David S Sanders, FRCP, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: diarrhoea; pancreatic exocrine insufficiency; gastrointestinal; faecal elastase; coeliac; creon
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Pancreatic Diseases; Diarrhea; Celiac Disease; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: STH16190