Clinical trial NCT02675283: Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting
Official title: Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coeliac Disease
Keywords: Point of care test
Diagnosis
Case finding
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: The prevalence of CD in this study cohort as a result of a case finding approach using a POCT in a pharmacy setting.
timeFrame: Baseline - 20 months
Secondary outcomes:
measure: The proportion of individuals agreeing to fill in the eligibility questionnaire.
timeFrame: Baseline - 20 months
measure: The proportion of individuals undertaking the POCT.
timeFrame: Baseline - 20 months
measure: The proportion of individuals undergoing a gastroscopy with duodenal biopsies.
timeFrame: Baseline - 20 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: David Sanders
role: PRINCIPAL_INVESTIGATOR
References: