Background of Different Phenotypes of Coeliac Disease

Recruiting

• Conditions: Celiac Disease; Dermatitis Herpetiformis
• Interventions: Genetic: Genetic predisposition

• Registration Number: NCT05597904
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Study Start: 2022-11-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coeliac disease patients	Genetic predisposition	Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis
Healthy controls	Genetic predisposition	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

Primary Outcome Measures

Name	Time	Method
Non-HLA variant association	baseline	phenotype specific non-HLA variants

Secondary Outcome Measures

Name	Time	Method
microbiata	baseline	skin and intestinal microbiata findings
serum transglutaminase antibodies	baseline	Levels of serum antibodies against transglutaminase
gastrointestinal symptoms	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)
dietary adherence	baseline	strictness of gluten-free diet (GIP-test)
quality of life measure	baseline	PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland