Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients

NCT07366151 | Not Yet Recruiting

• 1 other identifier: R24071
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.

Conditions

Intestinal Diseases; Gastrointestinal Disease; Digestive System Diseases; Celiac Disease; Malabsorption Syndromes

Keywords

Celiac disease; Potential celiac disease; Gluten-free diet; Screen detected; Long-term health; Quality of life; Symptoms; Asymptomatic

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal symptom rating scale (GSRS)

  Symptoms are measured with Gastrointestinal symptom rating scale (GSRS) questionnaire. The scoring consists of 15 items, which are scored with a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. Items cover five different symptoms (indigestion, diarrhea, abdominal pain, constipation and reflux) and values for each sub-dimension are calculated as a mean of the relevant items. The total GSRS score is described as a mean value of all 15 items (from 1 to 7 points). Scores of the participants are compared with the result of earlier study when possible.

  At the time of study visit

• Quality of life (PGWB)

  Quality of life is measured with Psychological General Well-Being (PGWB) questionnaire. The survey consists of 22 separate items covering six different sub-dimensions: anxiety, depression, well-being, self-control, general health and vitality. The scoring is based on a 6-grade Likert scale in which higher scores indicate better quality of life. The value of the total PGWB score may range from a minimum of 22 to maximum 132. The sub-scores are calculated as a sum of the items in each sub-dimensio. The PGWB results are compared with the result of earlier study when possible.

  At the time of study visit

Secondary Outcomes (8)

• Celiac disease diagnosis

  2-20 years

• Gluten-free diet

  The time of study visit

• Skin symptoms

  At the time of study visit

• BMI

  At the time of the study

• Nutritional status and general health

  2-20 years

Study Arms (2)

Screen detected CeD

Patients with confirmed celiac disease diagnosis found by screening of the disease

Potential CeD

Patients earlier diagnosed with potential celiac disease and patients who have had celiac disease antibody positivity, but were not investigated further. Current diagnostic and treatment status is mostly unknown.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of earlier study cohorts investigating potential or screen-detected celiac disease, irrespective of the current diagnostical status.

You may qualify if:

• Finnish citizenship and current residence in Finland

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• Finnish Medical Foundation: collaborator

Study Sites (1)

Tampere University, Faculty of Medicine and Health Technology

Tampere, 33520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Duodenal mucosal biopsies, mucosal samples (oral cavity), stool samples

MeSH Terms

Conditions

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Celiac Disease

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Kalle Kurppa, professor

CONTACT

+3582945211; kalle.kurppa@tuni.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: January 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)