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NCT Number: NCT05597904

Background of Different Phenotypes of Coeliac Disease

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.

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Key information

Conditions

Celiac Disease Autoimmune Diseases Dermatitis Dermatitis Herpetiformis Digestive System Diseases Gastrointestinal Diseases Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33521, Finland

Location status: Recruiting

Location contact

Teea T Salmi, Prof

CONTACT

[email protected]

+358 503016355

Teea T Salmi, Prof

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic predisposition

Genetic

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

Primary outcomes

  1. Non-HLA variant association

    Time frame: baseline

    phenotype specific non-HLA variants

Secondary outcomes

  1. serum transglutaminase antibodies

    Time frame: baseline

    Levels of serum antibodies against transglutaminase

  2. microbiata

    Time frame: baseline

    skin and intestinal microbiata findings

  3. quality of life measure

    Time frame: baseline

    PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)

  4. gastrointestinal symptoms

    Time frame: baseline

    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)

  5. dietary adherence

    Time frame: baseline

    strictness of gluten-free diet (GIP-test)

Study contacts

Contact information is provided by the study sponsor or research team.

Teea T Salmi, Prof

CONTACT

[email protected]

+358503016355

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Oslo University Hospital
  • Oulu University Hospital
  • Tampere University
  • University of Debrecen
  • University of Helsinki
  • University of Trieste
  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Oct 28, 2022
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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