Background of Different Phenotypes of Coeliac Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital
About this trial
The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis
Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient
Disqualifiers
Cohorts 1-3: Age <18 years
Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed
Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis
Trial population
National and also focused recruitment for patients with coeliac disease or dermatitis herpetiformis diagnosis. Healthy controls recruited via volunteered subjects with coeliac disease or dermatitis herpetiformis
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Genetic predisposition
GeneticAssessment of genetic predisposition to various celiac disease phenotypes. No intervention.
Treatment groups
3,500 Participants
are divided into 2 treatment groupsGroup A: Coeliac disease patients1 intervention
Group B: Healthy controls1 intervention
Trial outcomes
Primary outcomes
1
Non-HLA variant association
phenotype specific non-HLA variants
Time frame
baselineSecondary outcomes
1
serum transglutaminase antibodies
Levels of serum antibodies against transglutaminase
Time frame
baseline2
microbiata
skin and intestinal microbiata findings
Time frame
baseline3
quality of life measure
PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)
Time frame
baseline4
gastrointestinal symptoms
GSRS-questionnaire (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
University of Helsinki
Collaborator
University of Turku
Collaborator
Oulu University Hospital
Collaborator
University of Debrecen
Collaborator
University of Trieste
Collaborator
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov