Background of Different Phenotypes of Coeliac Disease

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597904
• Other study ID #: R22088
• Status: Recruiting
• Start date: November 8, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: Teea T Salmi, Prof
• Phone: +358503016355
• Email: teea.salmi[@]pshp.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Dermatitis
• Dermatitis Herpetiformis

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (8)

Lead Sponsor	Collaborator
Tampere University Hospital	Oslo University Hospital, Oulu University Hospital, Tampere University, University of Debrecen, University of Helsinki, University of Trieste, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-HLA variant association	phenotype specific non-HLA variants	baseline
Secondary	serum transglutaminase antibodies	Levels of serum antibodies against transglutaminase	baseline
Secondary	microbiata	skin and intestinal microbiata findings	baseline
Secondary	quality of life measure	PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)	baseline
Secondary	gastrointestinal symptoms	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)	baseline
Secondary	dietary adherence	strictness of gluten-free diet (GIP-test)	baseline