Celiac Disease Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
University of Eastern Finland
University of Turku
National Institute for Health and Welfare, Finland
Päivikki and Sakari Sohlberg Foundation, Finland
Kätilöopisto Maternity Hospital
Information provided by (Responsible Party):
Kuopio University Hospital

February 6, 2008
February 18, 2008
August 23, 2013
October 2007
August 2014   (Final data collection date for primary outcome measure)
development of transglutaminase antibodies [ Time Frame: 2-4 year age ]
Same as current
Complete list of historical versions of study NCT00617838 on Archive Site
  • gliadin peptide antibodies [ Time Frame: 2-4 years ]
  • mucosal biopsy in TGA positive childre [ Time Frame: 2-4 years ]
Same as current
Not Provided
Not Provided
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

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Celiac Disease
Other: Optimal gluten introduction
Optimization of gluten introduction by nutritional counselling
  • Active Comparator: 1
    Optimization of gluten introduction by nutritional councelling
    Intervention: Other: Optimal gluten introduction
  • No Intervention: 2
    No specific nutritional councelling. Follow-up of gluten introduction
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2014
August 2014   (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
Sexes Eligible for Study: All
up to 2 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Kuopio University Hospital
Kuopio University Hospital
  • University of Eastern Finland
  • University of Turku
  • National Institute for Health and Welfare, Finland
  • Päivikki and Sakari Sohlberg Foundation, Finland
  • Kätilöopisto Maternity Hospital
Principal Investigator: Jorma Ilonen, MD University of Eastern Finland
Kuopio University Hospital
August 2013

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