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Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Primary Purpose

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

Status

Terminated

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Creon

Placebo

About this trial

This is an interventional treatment trial for Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks) focused on measuring pancreatic exocrine insufficiency, faecal elastase, diarrhoea, coeliac, creon, gastrointestinal

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Creon

Arm 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.

Outcomes

Primary Outcome Measures

Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment

Secondary Outcome Measures

Quality of life

Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

body mass index

body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

Full Information

NCT ID

NCT01865695

First Posted

May 21, 2013

Last Updated

September 19, 2019

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01865695

Brief Title

Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Lack of participant enrolment

Study Start Date

May 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

pancreatic exocrine insufficiency, faecal elastase, diarrhoea, coeliac, creon, gastrointestinal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

Creon

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Creon

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Quality of life

Description

Quality of life on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

Time Frame

6 weeks

Title

body mass index

Description

body mass index on gastrointestinal symptoms in patients with low faecal pancreatic elastase following six weeks of treatment

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David S Sanders, FRCP

Organizational Affiliation

Sheffield Teaching Hospitals NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

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