Coeliac DiseaseNCT02675283
Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting
A study testing Simtomax in people with Coeliac Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coeliac Disease
- What is being tested?
- Simtomax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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
Who cannot join
- previous diagnosis of coeliac disease, or
- previous or current investigation for coeliac disease.
- age under 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting: A Feasibility Study
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.
Read the 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
- Being tested
- Simtomax
- Keywords
- Point of care test, Diagnosis, Case finding
- Medical subject headings
- Celiac Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimtomaxDevice
Also called Point of care test
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.
| Study group | Role | What they receive |
|---|---|---|
| coeliac disease point of care test | Other | Patients will be consented for a finger prick point of care test, Simtomax, at the pharmacy. Receives: Device: Simtomax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 20 months
Secondary outcomes (3)
The proportion of individuals agreeing to fill in the eligibility questionnaire.
Measured: Baseline - 20 months
The proportion of individuals undertaking the POCT.
Measured: Baseline - 20 months
The proportion of individuals undergoing a gastroscopy with duodenal biopsies.
Measured: Baseline - 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Sanders, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675283
- Sponsor's protocol ID
- STH19172
- Status last verified
- Nov 2017
- First submitted
- 25 Jan 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02675283
- Acronym / sponsor ID
- STH19172
- Conditions
- Coeliac Disease
- Keywords
- Point of care test, Diagnosis, Case finding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coeliac disease point of care test | Other | Device: SimtomaxPatients will be consented for a finger prick point of care test, Simtomax, at the pharmacy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 or over, and
- Purchasing gastrointestinal medications, including:
- Suffering from any of the following:
Key exclusion criteria (3 listed)
- previous diagnosis of coeliac disease, or
- previous or current investigation for coeliac disease.
- age under 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimtomaxAlso: Point of care testPatients 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. | Device | coeliac disease point of care test |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Coeliac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sanders principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simtomax in people with Coeliac Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.