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Completed

NCT Number: NCT02072590

Improved Diagnostics of Celiac Disease in Children

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.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital, Tampere, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suspicion of celiac disease or gluten sensitivity
  • Age below 18 years

Exclusion criteria

  • Study refusal
  • Age 18 years or more

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum endomysial antibodies

    Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

    Change of the endomysial antibody levels on a gluten-free diet

  2. Visual Analog Scale

    Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

    Change in the the subjective perception of health measured by Visual Analog Scale

  3. Dietary compliance

    Time frame: After 3 months, 6 months and 1 year on a gluten-free diet

    Adherence to the gluten-free diet

  4. Height

    Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

    Change of height (centimeters) on a gluten-free diet

  5. Weight

    Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

    Change of weight (kilograms) on a gluten-free diet

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Carol Davila University of Medicine and Pharmacy

Registry information

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2014
Registry last updated
Nov 24, 2023

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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