Malabsorption SyndromesNCT07366151
Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients
An observational study of Malabsorption Syndromes and Intestinal Diseases, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Disease
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2026to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of earlier study cohorts investigating potential or screen-detected celiac disease, irrespective of the current diagnostical status.
Who may be able to join
- Finnish citizenship and current residence in Finland
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Tampere University, Faculty of Medicine and Health Technology
Tampere, 33520
Kalle Kurppa, +3582945211, kalle.kurppa@tuni.fi
Pilvi Laurikka, M.D., Ph.D.
About this study
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
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.
Read the 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
- Keywords
- Celiac disease, Potential celiac disease, Gluten-free diet, Screen detected, Long-term health, Quality of life, Symptoms, Asymptomatic
- Medical subject headings
- Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of study visit
Secondary outcomes (8)
Celiac disease diagnosis
How many have received celiac disease diagnosis after previous study?
Measured: 2-20 years
Gluten-free diet
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.
Measured: The time of study visit
Skin symptoms
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
Measured: At the time of study visit
BMI
Weight (kilograms) and height (centimeters) will be combined as body mass index, kg/m2
Measured: At the time of the study
Nutritional status and general health
Interview and blood tests
Measured: 2-20 years
Bone mineral density
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.
Measured: At the time of the study visit
Modified Marsh-Oberhuber Classification
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.
Measured: 2-20 years
Villus hight-Crypt depth Ratio (Vh/CrD)
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.
Measured: 2-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malabsorption SyndromesStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Finnish Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366151
- Sponsor's protocol ID
- R24071
- Status last verified
- Jan 2026
- First submitted
- 2 May 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07366151
- Acronym / sponsor ID
- R24071
- Conditions
- Malabsorption Syndromes, Intestinal Diseases, Gastrointestinal Disease, Digestive System Diseases, Celiac Disease
- Keywords
- Celiac disease, Potential celiac disease, Gluten-free diet, Screen detected, Long-term health, Quality of life, Symptoms, Asymptomatic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Finnish Medical Foundation
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of earlier study cohorts investigating potential or screen-detected celiac disease, irrespective of the current diagnostical status.
Key inclusion criteria (1 listed)
- Finnish citizenship and current residence in Finland
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malabsorption Syndromes and Intestinal Diseases, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kalle Kurppa, professor (+3582945211, kalle.kurppa@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptom rating scale (GSRS) (time frame: At the time of study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.