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Sponsors and Collaborators: |
Kuopio University Hospital University of Kuopio University of Turku National Public Health Institute Päivikki and Sakari Sohlberg Foundation |
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Information provided by: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT00617838 |
Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial cells and microvilli on gut mucosa is causing a "flat mucosa" and an absorption defect. The diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies to tissue transglutaminase and certain gliadin peptides are strongly associated with the pathology. Severe diarrhoea associated with growth disturbance in infancy was historically characterising the disease but is nowadays rare. Clinically more mild forms including silent disease are very common. Studies based on antibody screening and biopsies done in autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population. Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been recently found that undiagnosed celiac disease may be associated with general underachievement in society probably associated with common psychological symptoms like fatigue and depression during the adolescence. The disease is treated by complete elimination of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs in nutrition.
Much progress has been recently made in understanding of the genetic background and immune markers associated with the disease as well as in understanding those patterns of gluten introduction in infancy, which might be connected to a high disease risk. Our aim in this study is in the first phase to identify children at high genetic risk (around 10%) and in a follow-up study to define:
If we can confirm, that optimising the conditions at the introduction of wheat gluten in infancy diet significantly reduces the disease incidence, will this have an important effect on the nutritional recommendations concerning the diet in infancy. Combining genetic screening and immunological tests might also offer a way to reduce the frequency of celiac disease and help in early diagnosis and organisation of an adequate treatment
Condition | Intervention |
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Celiac Disease |
Other: Optimal gluten introduction |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization |
Estimated Enrollment: | 316 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Optimization of gluten introduction by nutritional councelling
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Other: Optimal gluten introduction
Optimization of gluten introduction by nutritional counselling
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2: No Intervention
No specific nutritional councelling. Follow-up of gluten introduction
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Ages Eligible for Study: | up to 2 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Bjork, MSc | +358 17 173311 | anne.bjork@kuh.fi |
Finland | |
Kuopio University Hospital | Recruiting |
Kuopio, Finland, FIN-70211 | |
Principal Investigator: Pekka Arikoski, ID |
Principal Investigator: | Jorma Ilonen, MD | University of Kuopio |
Responsible Party: | University of Kuopio ( Jorma Ilonen/ Professor ) |
Study ID Numbers: | KUH5021612 |
Study First Received: | February 6, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00617838 |
Health Authority: | Finland: Ethics Committee |
Celiac disease genetic risk gluten introduction predicting antibodies |
Antibodies Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases Immunoglobulins |