Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02675283|
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coeliac Disease||Device: Simtomax||Not Applicable|
Coeliac disease (CD) is an autoimmune condition characterised by mucosal damage of the small intestine by dietary gluten. CD affects 1 in 100 people. However, patients do not always have symptoms, resulting in 5 undiagnosed patients to every known case of CD. Undiagnosed CD can lead to complications such as vitamin and mineral deficiencies, osteoporosis and small bowel lymphoma, as well as impairing quality of life.
Currently, patients are diagnosed with a conventional blood test for coeliac antibodies (anti-TTG) as a first line test. Simtomax®, a new coeliac point of care test (POCT), has become available. It is a finger prick test that provides results of a coeliac antibody, deaminated gliadin peptide, within 10 minutes. Studies showed that Simtomax is as accurate as anti-TTG, with a 92.7% chance of detecting CD and 98.7% chance of ruling out CD.
This study aims to assess whether the POCT can increase the detection of adult coeliac disease when used in a pharmacy setting. A feasibility study using a case-finding approach will be conducted at 5 pharmacies in Sheffield over 20 months. It will be funded by Professor Sanders' research funds.
Customers who enter the pharmacies will be approached by the principal investigator (PI). Eligible participants (those with symptoms suggestive of or risk factors for CD) will be consented for the POCT by the PI. The POCT will be carried out at the pharmacies. Any participant with a positive test will be advised to see his GP to be referred for a gastroscopy at the Royal Hallamshire Hospital to confirm the diagnosis. Once diagnosed, the participant will follow the standard management pathway for any patients with CD.
Results of the study will be compared to the established prevalence of CD of 1%, to assess whether using POCT in a pharmacy setting can increase the detection of adult CD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||502 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting: A Feasibility Study|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
coeliac disease point of care test
Patients will be consented for a finger prick point of care test, Simtomax, at the pharmacy.
Patients will undertake a finger prick point of care test, Simtomax, at the pharmacy. A sample of 25 μl of capillary venous blood is required which can be obtained through a simple finger prick technique. The sample is then applied to the test device, followed by the application of 5 drops of the provided buffer solution. The result can be read after 10 minutes. Positive results are indicated by the presence of a solid red line, with a single line for a combined IgA and IgG DGP positivity, and a single line for the presence of total IgA. An in-built control line ensures a correctly functioning test.
Other Name: Point of care test
- The prevalence of CD in this study cohort as a result of a case finding approach using a POCT in a pharmacy setting. [ Time Frame: Baseline - 20 months ]This feasibility study will describe the prevalence of CD in this study cohort. This will be compared to the established prevalence of CD of 1% in the general population.
- The proportion of individuals agreeing to fill in the eligibility questionnaire. [ Time Frame: Baseline - 20 months ]
- The proportion of individuals undertaking the POCT. [ Time Frame: Baseline - 20 months ]
- The proportion of individuals undergoing a gastroscopy with duodenal biopsies. [ Time Frame: Baseline - 20 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675283
|Sheffield Teaching Hospitals|
|Sheffield, United Kingdom, S10 2JF|
|Principal Investigator:||David Sanders||Sheffield Teaching Hospitals NHS Foundation Trust|