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Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting

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ClinicalTrials.gov Identifier: NCT02675283
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
This study aims to assess whether it is feasible to use a point of care test to increase the detection of coeliac disease in a pharmacy setting.

Condition or disease Intervention/treatment Phase
Coeliac Disease Device: Simtomax Not Applicable

Detailed Description:

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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Arm Intervention/treatment
coeliac disease point of care test
Patients will be consented for a finger prick point of care test, Simtomax, at the pharmacy.
Device: Simtomax
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The proportion of individuals agreeing to fill in the eligibility questionnaire. [ Time Frame: Baseline - 20 months ]
  2. The proportion of individuals undertaking the POCT. [ Time Frame: Baseline - 20 months ]
  3. The proportion of individuals undergoing a gastroscopy with duodenal biopsies. [ Time Frame: Baseline - 20 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 or over, and
  2. Purchasing gastrointestinal medications, including:

    • Over the counter medications (i.e. medicines purchasable without a prescription or supervision of a pharmacist)
    • Pharmacy medications (i.e. medicines purchasable from a pharmacy without a prescription but provided under the supervision of a pharmacist. These medicines are kept 'behind the counter' and are not available on the pharmacy shelves.)
    • Prescription only medications (i.e. medicines only available with a prescription that is issued by a GP or another suitably qualified healthcare professional), and/ or
  3. Suffering from any of the following:

    • Persistent unexplained abdominal or gastrointestinal symptoms
    • Prolonged fatigue
    • Unexpected weight loss
    • Severe or persistent mouth ulcers
    • Unexplained iron, vitamin B12 or folate deficiency
    • Type 1 diabetes
    • Autoimmune thyroid disease
    • Irritable bowel syndrome
    • Metabolic bone disorder (reduced bone mineral density or osteomalacia)
    • Unexplained neurological symptoms (particularly peripheral neuropathy or ataxia)
    • Unexplained subfertility or recurrent miscarriage
    • Persistently raised liver enzymes
    • Dental enamel defects, and/ or 4 Have first degree relatives with coeliac disease

Exclusion Criteria:

  • previous diagnosis of coeliac disease, or
  • previous or current investigation for coeliac disease.
  • age under 18.

Information from the National Library of Medicine

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


Locations
United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: David Sanders Sheffield Teaching Hospitals NHS Foundation Trust

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02675283     History of Changes
Other Study ID Numbers: STH19172
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Point of care test
Diagnosis
Case finding

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases