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Celiac Disease Prevention
This study is currently recruiting participants.
Study NCT00617838   Information provided by Kuopio University Hospital
First Received: February 6, 2008   Last Updated: August 20, 2009   History of Changes

February 6, 2008
August 20, 2009
October 2007
December 2012   (final data collection date for primary outcome measure)
development of transglutaminase antibodies [ Time Frame: 2-4 year age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00617838 on ClinicalTrials.gov Archive Site
  • gliadin peptide antibodies [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]
  • mucosal biopsy in TGA positive childre [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]
Same as current
 
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:

  1. Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
  2. Is it possible to decrease the frequency of celiac disease by nutritional counselling?
  3. 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

 
 
Interventional
Prevention, Randomized, Single Blind (Subject), Parallel Assignment
Celiac Disease
Other: Optimal gluten introduction
  • Active Comparator: Optimization of gluten introduction by nutritional councelling
  • No Intervention: No specific nutritional councelling. Follow-up of gluten introduction
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
316
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of HLA-risk alleles DQA1*05 and DQB1*02

Exclusion Criteria:

  • Lack of these HLA risk alleles
Both
up to 2 Months
Yes
Contact: Anne Bjork, MSc +358 17 173311 anne.bjork@kuh.fi
Finland
 
NCT00617838
Jorma Ilonen/ Professor, University of Kuopio
KUH5021612
Kuopio University Hospital
  • University of Kuopio
  • University of Turku
  • National Public Health Institute
  • Päivikki and Sakari Sohlberg Foundation
  • Kätilöopisto Maternity Hospital
Principal Investigator: Jorma Ilonen, MD University of Kuopio
Kuopio University Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP