Trials / Not Yet Recruiting
Not Yet RecruitingNCT07366151
Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients
The Impact of Active Screening on the Long-term Health of Celiac Disease Patients and the Natural Course of Potential Untreated or Treated Celiac Disease
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Tampere University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
In this retrospective observational cohort study, participants from earlier studies conducted by the Tampere Celiac Disease Research Center are invited for a follow-up visit. The study cohorts include individuals with screen-detected celiac disease (CeD), potential CeD, and subjects previously investigated due to positive CeD serology, but with an unknown diagnostic status. The participants are interviewed and complete structured questionnaires. Blood, urine, stool, and mucosal samples are collected for both routine clinical assessment and research purposes. Bone mineral density is measured using DXA, and a skin biopsy is offered to assess for latent dermatitis herpetiformis. Esophagogastroduodenoscopy is offered to participants with potential CeD who are on a gluten-containing diet, as well as to those experiencing challenges with dietary treatment. Clinical results are compared with healthy relatives and previously studied, treated CeD controls.
Conditions
- Malabsorption Syndromes
- Intestinal Diseases
- Gastrointestinal Disease
- Digestive System Diseases
- Celiac Disease
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2034-12-01
- Completion
- 2034-12-01
- First posted
- 2026-01-26
- Last updated
- 2026-01-26
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT07366151. Inclusion in this directory is not an endorsement.