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Background of Different Phenotypes of Coeliac Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05597904
Enrollment
3500
Registered
2022-10-28
Start date
2022-11-08
Completion date
2030-12-31
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Dermatitis Herpetiformis

Keywords

coeliac disease, dermatitis herpetiformis, gluten-free diet, transglutaminase, microbiata

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.

Interventions

GENETICGenetic predisposition

Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.

Sponsors

Tampere University
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
University of Turku
CollaboratorOTHER
Oulu University Hospital
CollaboratorOTHER
University of Debrecen
CollaboratorOTHER
University of Trieste
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Non-HLA variant associationbaselinephenotype specific non-HLA variants

Secondary

MeasureTime frameDescription
serum transglutaminase antibodiesbaselineLevels of serum antibodies against transglutaminase
microbiatabaselineskin and intestinal microbiata findings
quality of life measurebaselinePGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)
gastrointestinal symptomsbaselineGSRS-questionnaire (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)
dietary adherencebaselinestrictness of gluten-free diet (GIP-test)

Countries

Finland

Contacts

Primary ContactTeea T Salmi, Prof
teea.salmi@pshp.fi+358503016355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026