Celiac DiseaseNCT02072590
Improved Diagnostics of Celiac Disease in Children
An observational study of Celiac Disease and Eosinophilic Esophagitis, run by Tampere University Hospital at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Celiac Disease, Eosinophilic Esophagitis
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2011to 21 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Hospital clinic; secondary and tertiary centers
Who may be able to join
- Suspicion of celiac disease or gluten sensitivity
- Age below 18 years
Who cannot join
- Study refusal
- Age 18 years or more
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site
Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
Tampere, 33520
Romania1 site
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Bucharest
About this study
The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.
Read the detailed description
Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.
- Conditions
- Celiac Disease, Eosinophilic Esophagitis
- Keywords
- Celiac disease, Eosinophilic esophagitis, Endomysial antibodies, Transglutaminase antibodies, Small-bowel
- Medical subject headings
- Celiac Disease, Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Transglutaminase 2 antibodies
Change of the transglutaminase 2 antibody levels on a gluten-free diet
Measured: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Secondary outcomes (5)
Serum endomysial antibodies
Change of the endomysial antibody levels on a gluten-free diet
Measured: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Visual Analog Scale
Change in the the subjective perception of health measured by Visual Analog Scale
Measured: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Dietary compliance
Adherence to the gluten-free diet
Measured: After 3 months, 6 months and 1 year on a gluten-free diet
Height
Change of height (centimeters) on a gluten-free diet
Measured: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Weight
Change of weight (kilograms) on a gluten-free diet
Measured: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startAug 2011
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy
- Responsible party
- Sponsor
- Investigators
- Kalle Kurppa, MD, Principal investigator, Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072590
- Sponsor's protocol ID
- R11187
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2014
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurppa K, Ashorn M, Iltanen S, Koskinen LL, Saavalainen P, Koskinen O, Maki M, Kaukinen K. Celiac disease without villous atrophy in children: a prospective study. J Pediatr. 2010 Sep;157(3):373-80, 380.e1. doi: 10.1016/j.jpeds.2010.02.070. Epub 2010 Apr 18.
PubMed 20400102Popp A, Mihu M, Munteanu M, Ene A, Dutescu M, Colcer F, Raducanu D, Laurila K, Anca I, Maki M. Prospective antibody case finding of coeliac disease in type-1 diabetes children: need of biopsy revisited. Acta Paediatr. 2013 Mar;102(3):e102-6. doi: 10.1111/apa.12117. Epub 2013 Jan 4.
PubMed 23211000Taavela J, Koskinen O, Huhtala H, Lahdeaho ML, Popp A, Laurila K, Collin P, Kaukinen K, Kurppa K, Maki M. Validation of morphometric analyses of small-intestinal biopsy readouts in celiac disease. PLoS One. 2013 Oct 11;8(10):e76163. doi: 10.1371/journal.pone.0076163. eCollection 2013.
PubMed 24146832Popp A, Taavela J, Arvola T, Kaukinen K, Maki M, Kurppa K. Bulb biopsies for diagnosing celiac disease in children: A prospective multicenter study using quantitative histomorphometry. J Pediatr Gastroenterol Nutr. 2026 Jan;82(1):129-136. doi: 10.1002/jpn3.70255. Epub 2025 Nov 6.
PubMed 41195622Repo M, Lindfors K, Maki M, Huhtala H, Laurila K, Lahdeaho ML, Saavalainen P, Kaukinen K, Kurppa K. Anemia and Iron Deficiency in Children With Potential Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):56-62. doi: 10.1097/MPG.0000000000001234.
PubMed 27101536Rajalahti T, Repo M, Kivela L, Huhtala H, Maki M, Kaukinen K, Lindfors K, Kurppa K. Anemia in Pediatric Celiac Disease: Association With Clinical and Histological Features and Response to Gluten-free Diet. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):e1-e6. doi: 10.1097/MPG.0000000000001221.
PubMed 27035377
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnostics of Celiac Disease in Children
- ClinicalTrials.gov ID
- NCT02072590
- Acronym / sponsor ID
- R11187
- Conditions
- Celiac Disease, Eosinophilic Esophagitis
- Keywords
- Celiac disease, Eosinophilic esophagitis, Endomysial antibodies, Transglutaminase antibodies, Small-bowel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy
- Study start
- Aug 2011
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 26 Feb 2014 (estimated)
- 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 main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.
Detailed description
Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospital clinic; secondary and tertiary centers
Key inclusion criteria (2 listed)
- Suspicion of celiac disease or gluten sensitivity
- Age below 18 years
Key exclusion criteria (2 listed)
- Study refusal
- Age 18 years or more
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
Transglutaminase 2 antibodies
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change of the transglutaminase 2 antibody levels on a gluten-free diet
5 secondary outcomes
Serum endomysial antibodies
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Visual Analog Scale
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Dietary compliance
Time frame: After 3 months, 6 months and 1 year on a gluten-free diet
Height
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Weight
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 20400102Kurppa K, Ashorn M, Iltanen S, Koskinen LL, Saavalainen P, Koskinen O, Maki M, Kaukinen K. Celiac disease without villous atrophy in children: a prospective study. J Pediatr. 2010 Sep;157(3):373-80, 380.e1. doi: 10.1016/j.jpeds.2010.02.070. Epub 2010 Apr 18.
- Background: PubMed 23211000Popp A, Mihu M, Munteanu M, Ene A, Dutescu M, Colcer F, Raducanu D, Laurila K, Anca I, Maki M. Prospective antibody case finding of coeliac disease in type-1 diabetes children: need of biopsy revisited. Acta Paediatr. 2013 Mar;102(3):e102-6. doi: 10.1111/apa.12117. Epub 2013 Jan 4.
- Background: PubMed 24146832Taavela J, Koskinen O, Huhtala H, Lahdeaho ML, Popp A, Laurila K, Collin P, Kaukinen K, Kurppa K, Maki M. Validation of morphometric analyses of small-intestinal biopsy readouts in celiac disease. PLoS One. 2013 Oct 11;8(10):e76163. doi: 10.1371/journal.pone.0076163. eCollection 2013.
- Derived from this study: PubMed 41195622Popp A, Taavela J, Arvola T, Kaukinen K, Maki M, Kurppa K. Bulb biopsies for diagnosing celiac disease in children: A prospective multicenter study using quantitative histomorphometry. J Pediatr Gastroenterol Nutr. 2026 Jan;82(1):129-136. doi: 10.1002/jpn3.70255. Epub 2025 Nov 6.
- Derived from this study: PubMed 27101536Repo M, Lindfors K, Maki M, Huhtala H, Laurila K, Lahdeaho ML, Saavalainen P, Kaukinen K, Kurppa K. Anemia and Iron Deficiency in Children With Potential Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):56-62. doi: 10.1097/MPG.0000000000001234.
- Derived from this study: PubMed 27035377Rajalahti T, Repo M, Kivela L, Huhtala H, Maki M, Kaukinen K, Lindfors K, Kurppa K. Anemia in Pediatric Celiac Disease: Association With Clinical and Histological Features and Response to Gluten-free Diet. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):e1-e6. doi: 10.1097/MPG.0000000000001221.
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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. This study is not recruiting at the moment.
Kalle Kurppa, MD principal investigator
Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Eosinophilic Esophagitis, run by Tampere University Hospital at 2 sites in 2 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transglutaminase 2 antibodies (time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02072590, which also lists 6 linked publications.
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 24 Nov 2023.