Background of Different Phenotypes of Coeliac Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05597904
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tampere University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease, Dermatitis Herpetiformis
Additional Details

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.

Arms & Interventions

Arms

: Coeliac disease patients

Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis

: 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

Interventions

Genetic: - Genetic predisposition

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tampere University Hospital, Tampere, Finland

Status

Recruiting

Address

Tampere University Hospital

Tampere, , 33521

Site Contact

Teea T Salmi, Prof

teea.salmi@tuni.fi

+358 503016355

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