Background of Different Phenotypes of Coeliac Disease

NCT ID: NCT05597904

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Celiac Disease Dermatitis Herpetiformis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Coeliac disease patients

Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis

Genetic predisposition

Intervention Type GENETIC

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

Healthy controls

500 adult (18 years or over) friends or non-related family members of coeliac disease or dermatitis herpetiformis patients participating in the study, no previous coeliac disease or dermatitis herpetiformis diagnosis. In addition 1000 controls will be included from Biobank

Genetic predisposition

Intervention Type GENETIC

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

Interventions

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Genetic predisposition

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Debrecen

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Teea Salmi

Professor in Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Teea T Salmi, Prof

Role: CONTACT

+358503016355

Facility Contacts

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Teea T Salmi, Prof

Role: primary

+358 503016355

Other Identifiers

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R22088

Identifier Type: -

Identifier Source: org_study_id

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