Background of Different Phenotypes of Coeliac Disease | NCT05597904

Studies
Background of Different Phenotypes of Coeliac Disease

NCT05597904

Sponsor

Tampere University Hospital

Status

Recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Celiac Disease
Dermatitis Herpetiformis

Interventions

Genetic predisposition

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Oct 3, 2022

First Submission Date that Met QC Criteria

Oct 25, 2022

First Posted Date

Oct 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Teea Salmi, Professor in Dermatology, Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Name	Class
Tampere University	OTHER
University of Helsinki	OTHER
University of Turku	OTHER
Oulu University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coeliac disease patients		Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis	Genetic: Genetic predisposition
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: Genetic predisposition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic predisposition	Genetic	Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.	Coeliac disease patients Healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-HLA variant association	phenotype specific non-HLA variants	baseline

Secondary Outcomes

Measure	Description	Time Frame
serum transglutaminase antibodies	Levels of serum antibodies against transglutaminase	baseline
microbiata	skin and intestinal microbiata findings

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

National and also focused recruitment for patients with coeliac disease or dermatitis herpetiformis diagnosis. Healthy controls recruited via volunteered subjects with coeliac disease or dermatitis herpetiformis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Teea T Salmi, Prof	Contact	+358503016355		teea.salmi@pshp.fi

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital	Recruiting	Tampere		33521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease
D003874	Dermatitis Herpetiformis

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided