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NCT Number: NCT07366151

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University, Faculty of Medicine and Health Technology

Tampere, 33520, Finland

Location contact

Kalle Kurppa

CONTACT

[email protected]

+3582945211

Pilvi Laurikka, M.D., Ph.D.

SUB_INVESTIGATOR

Saana Paavola, M.D., Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Finnish citizenship and current residence in Finland

Exclusion criteria

  • Age <18 years

Treatment and study plan

Primary outcomes

  1. Gastrointestinal symptom rating scale (GSRS)

    Time frame: At the time of study visit

    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.

  2. Quality of life (PGWB)

    Time frame: At the time of study visit

    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.

Secondary outcomes

  1. Celiac disease diagnosis

    Time frame: 2-20 years

    How many have received celiac disease diagnosis after previous study?

  2. Gluten-free diet

    Time frame: The time of study visit

    Adherence to the dietary treatment, when initiated is assessed by food diaries and Celiac Disease Adherence Test (CDAT) questionnaire. CDAT questionnaire is a 7-item questionnaire. Scoring is from 7 to 35, in which lower scores indicate good adherence and higher scores point towards poor adherence to gluten-free diet.

  3. Skin symptoms

    Time frame: At the time of study visit

    Interview and Dermatology Life Quality Index (DLQI) questionnaire. The DLQI is dermatology-spesific index with 10 questonnaire considering the impact of skin disease to quality of life during the last week. Each question is scored with a 4-point Likert scale (0-3), giving the total DLQI score from 0 to 30, a higher score indicating worse quality of life

  4. BMI

    Time frame: At the time of the study

    Weight (kilograms) and height (centimeters) will be combined as body mass index, kg/m2

  5. Nutritional status and general health

    Time frame: 2-20 years

    Interview and blood tests

  6. Bone mineral density

    Time frame: At the time of the study visit

    Bone mineral density is assessed with Duel-energy WX-ray Absorptiometry (DXA). In DXA, T-score compares bone mineral density to values of young, healthy adult. T-score -2.5 or lower indicates osteoporosis and score between -1.0 and -2.4 indicates osteopenia.

  7. Modified Marsh-Oberhuber Classification

    Time frame: 2-20 years

    Duodenal histology is evaluated with morphological description and Modified Marsh-Oberhuber classification. In this classification Marsh 0 means entirely normal mucosa, Marsh 1 indicates normal villi and crypts with increased intraepithelial lymphocytes (IEL), Marsh 2 for increased IELs and crypt hyperplasia. Marsh 3 a-c villus atrophy is combined to increased IELs and cryp hyperplasia: Class 3a partial villus atrophy, 3b for subtotal villus atrophy and 3c for total villus atrophy.

  8. Villus hight-Crypt depth Ratio (Vh/CrD)

    Time frame: 2-20 years

    Vh/CrD is a morphometric method to assess duodenal histology in addition to classifications like Marsh-Oberhuber. From several well-oriented duodenal samples, villous hight and crypt depth are measured. Ratio <2.0 indicates active celiac disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Kalle Kurppa, professor

CONTACT

[email protected]

+3582945211

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Finnish Medical Foundation
  • Tampere University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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