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Celiac Disease Prevention
Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization
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
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kuopio, Finland, FIN-70211
- Kuopio University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Presence of HLA-risk alleles DQA1*05 and DQB1*02
Exclusion Criteria:
- Lack of these HLA risk alleles
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 1
Optimization of gluten introduction by nutritional councelling
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Optimization of gluten introduction by nutritional counselling
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Geen tussenkomst: 2
No specific nutritional councelling.
Follow-up of gluten introduction
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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development of transglutaminase antibodies
Tijdsspanne: 2-4 year age
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2-4 year age
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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gliadin peptide antibodies
Tijdsspanne: 2-4 years
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2-4 years
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mucosal biopsy in TGA positive childre
Tijdsspanne: 2-4 years
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2-4 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jorma Ilonen, MD, University of Eastern Finland
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KUH5021612
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