Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Disease, Digestive System Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Gastrointestinal symptom rating scale (GSRS) [Time frame: At the time of study visit]
- Quality of life (PGWB) [Time frame: At the time of study visit]
Secondary outcome measures (8)
- Celiac disease diagnosis [Time frame: 2-20 years]
- Gluten-free diet [Time frame: The time of study visit]
- Skin symptoms [Time frame: At the time of study visit]
- BMI [Time frame: At the time of the study]
- Nutritional status and general health [Time frame: 2-20 years]
- Bone mineral density [Time frame: At the time of the study visit]
- Modified Marsh-Oberhuber Classification [Time frame: 2-20 years]
- Villus hight-Crypt depth Ratio (Vh/CrD) [Time frame: 2-20 years]
Eligibility criteria
Inclusion criteria
- Finnish citizenship and current residence in Finland
Exclusion criteria
- Age <18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- Tampere University, Faculty of Medicine and Health Technology — Tampere
Identifiers
NCT: NCT07366151 · R24071