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

NCT ID: NCT02675283

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-10-31

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.

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.

Conditions

Coeliac Disease

Keywords

Point of care test; Diagnosis; Case finding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

coeliac disease point of care test

Patients will be consented for a finger prick point of care test, Simtomax, at the pharmacy.

Group Type: OTHER

Simtomax

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Point of care test

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Sanders

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

STH19172

Identifier Type: -

Identifier Source: org_study_id