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

Tampere University Hospital

Status: Begins enrollment this month

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

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT07366151

R24071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Finnish citizenship and current residence in Finland

Exclusion criteria

• Age <18 years

Trial design

250 participants in 2 patient groups

Screen detected CeD

Description:

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

Potential CeD

Description:

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.