Skip to main content
Clinical Trials/NCT05597904
NCT05597904
Recruiting
Not Applicable

Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease

Tampere University Hospital1 site in 1 country3,500 target enrollmentNovember 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Celiac Disease
Sponsor
Tampere University Hospital
Enrollment
3500
Locations
1
Primary Endpoint
Non-HLA variant association
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Detailed Description

The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines. In this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

Registry
clinicaltrials.gov
Start Date
November 8, 2022
End Date
December 31, 2030
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Teea Salmi

Professor in Dermatology

Tampere University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Non-HLA variant association

Time Frame: baseline

phenotype specific non-HLA variants

Secondary Outcomes

  • microbiata(baseline)
  • serum transglutaminase antibodies(baseline)
  • quality of life measure(baseline)
  • gastrointestinal symptoms(baseline)
  • dietary adherence(baseline)

Study Sites (1)

Loading locations...

Similar Trials