Celiac Disease Prevention
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|ClinicalTrials.gov Identifier: NCT00617838|
Recruitment Status : Unknown
Verified August 2013 by Kuopio University Hospital.
Recruitment status was: Active, not recruiting
First Posted : February 18, 2008
Last Update Posted : August 23, 2013
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:
- Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
- Is it possible to decrease the frequency of celiac disease by nutritional counselling?
- Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion
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 or disease||Intervention/treatment||Phase|
|Celiac Disease||Other: Optimal gluten introduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: 1
Optimization of gluten introduction by nutritional councelling
Other: Optimal gluten introduction
Optimization of gluten introduction by nutritional counselling
No Intervention: 2
No specific nutritional councelling. Follow-up of gluten introduction
- development of transglutaminase antibodies [ Time Frame: 2-4 year age ]
- gliadin peptide antibodies [ Time Frame: 2-4 years ]
- mucosal biopsy in TGA positive childre [ Time Frame: 2-4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617838
|Kuopio University Hospital|
|Kuopio, Finland, FIN-70211|
|Principal Investigator:||Jorma Ilonen, MD||University of Eastern Finland|