Evidence-based Screening Strategies for Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03136731
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):
Katri Kaukinen, Tampere University Hospital

Brief Summary:
Main aim: To find evidence-based screening strategies for celiac disease in high risk groups and to find new biomarkers or biomarker combinations for celiac disease diagnostics and follow-up.

Condition or disease Intervention/treatment
Celiac Disease Diagnostic Test: Celiac disease antibody screening

Detailed Description:
The current project will result in the identification of genetic, environmental or downstream biomedical markers that predict the development of celiac disease at the individual level. Moreover, the markers can be exploited in prediction of specific disease risks, manifestations, comorbidities and complications.

Study Type : Observational
Estimated Enrollment : 3517 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Case-finding Strategies for Celiac Disease in Family Members: a Follow-up Study
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Group/Cohort Intervention/treatment
Healthy family members of celiac disease
Celiac disease screening, no intervention.
Diagnostic Test: Celiac disease antibody screening
Observational parameters

Celiac disease index cases
Assessment of disease related factors, no intervention.

Primary Outcome Measures :
  1. Forthcoming celiac disease diagnosed by current diagnostic criteria [ Time Frame: With in 10 years ]
    Assessed by positive transglutaminase antibodies, small bowel mucosal villous atrophy

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers; cohort 1, 3217 genetically predisposed healthy family members of celiac disease patients (high risk group for celiac disease), Cohort 2, 200 new celiac disease index cases will be enrolled

Inclusion Criteria:

  • Cohort 1: Family member of celiac disease patient
  • Cohort 2: Previously diagnosed celiac disease

Exclusion Criteria:

  • Cohort 1: No previous celiac disease
  • Cohort 2: Celiac disease diagnosis not confirmed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03136731

Contact: Katri Kaukinen, Professor +358 3 3116 111

Tampere University Hospital / Tampere University Recruiting
Tampere, Finland, 33521
Contact: Katri Kaukinen, Professor    +358 3355111   
Sponsors and Collaborators
Katri Kaukinen

Responsible Party: Katri Kaukinen, Professor, MD PhD, Tampere University Hospital Identifier: NCT03136731     History of Changes
Other Study ID Numbers: Celiac2017
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katri Kaukinen, Tampere University Hospital:
Celiac disease, Gluten, Microbiome, Genetic

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs