Celiac DiseaseNCT05597904
Background of Different Phenotypes of Coeliac Disease
An observational study of Celiac Disease and Dermatitis Herpetiformis, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Dermatitis Herpetiformis
- What is being tested?
- Genetic predisposition
- How many people
- 3,500 participants
- Where
- 1 siteFinland
- Study dates
- 8 Nov 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, 33521
Teea T Salmi, Prof, +358 503016355, teea.salmi@tuni.fi
Teea T Salmi, Prof
About this study
Official title: Genetic and Biological Background and Follow-up 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.
Read the 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.
- Conditions
- Celiac Disease, Dermatitis Herpetiformis
- Being tested
- Genetic predisposition
- Keywords
- coeliac disease, dermatitis herpetiformis, gluten-free diet, transglutaminase, microbiata
- Medical subject headings
- Celiac Disease, Dermatitis Herpetiformis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic predispositionGenetic
Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Coeliac disease patients | Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis Receives: 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 Receives: Genetic: Genetic predisposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-HLA variant association
phenotype specific non-HLA variants
Measured: baseline
Secondary outcomes (5)
serum transglutaminase antibodies
Levels of serum antibodies against transglutaminase
Measured: baseline
microbiata
skin and intestinal microbiata findings
Measured: baseline
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)
Measured: baseline
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)
Measured: baseline
dietary adherence
strictness of gluten-free diet (GIP-test)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start8 Nov 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki, University of Turku, Oulu University Hospital, University of Debrecen, University of Trieste, Oslo University Hospital
- Responsible party
- Principal investigator, Teea Salmi, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597904
- Sponsor's protocol ID
- R22088
- Status last verified
- Sep 2025
- First submitted
- 3 Oct 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease
- ClinicalTrials.gov ID
- NCT05597904
- Acronym / sponsor ID
- R22088
- Conditions
- Celiac Disease, Dermatitis Herpetiformis
- Keywords
- coeliac disease, dermatitis herpetiformis, gluten-free diet, transglutaminase, microbiata
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki, University of Turku, Oulu University Hospital, University of Debrecen, University of Trieste, Oslo University Hospital
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coeliac disease patients | – | Genetic: Genetic predispositionAdult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis |
| Healthy controls | – | Genetic: Genetic predisposition500 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic predispositionAssessment of genetic predisposition to various celiac disease phenotypes. No intervention. | Genetic | Coeliac disease patients, Healthy controls |
Primary outcome
Non-HLA variant association
Time frame: baseline
phenotype specific non-HLA variants
5 secondary outcomes
serum transglutaminase antibodies
Time frame: baseline
microbiata
Time frame: baseline
quality of life measure
Time frame: baseline
gastrointestinal symptoms
Time frame: baseline
dietary adherence
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Dermatitis Herpetiformis, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teea T Salmi, Prof (+358503016355, teea.salmi@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-HLA variant association (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.