NCT02675283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

January 25, 2016

Last Update Submit

November 22, 2017

Conditions

Coeliac Disease

Keywords

Point of care testDiagnosisCase finding

Outcome Measures

Primary Outcomes (1)

  • The prevalence of CD in this study cohort as a result of a case finding approach using a POCT in a pharmacy setting.

    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.

    Baseline - 20 months

Secondary Outcomes (3)

  • The proportion of individuals agreeing to fill in the eligibility questionnaire.

    Baseline - 20 months

  • The proportion of individuals undertaking the POCT.

    Baseline - 20 months

  • The proportion of individuals undergoing a gastroscopy with duodenal biopsies.

    Baseline - 20 months

Study Arms (1)

coeliac disease point of care test

OTHER

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

Device: Simtomax

Interventions

SimtomaxDEVICE

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.

Also known as: Point of care test
coeliac disease point of care test

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or over, and
  • 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
  • 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)
  • +4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Celiac DiseaseDisease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Sanders

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 5, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 24, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)