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This long-term interventional study (ClinicalTrials.gov ID #: NCT00617838) will include a target study population of 1,890, to be enrolled by the age of 2 months and to include both healthy subjects and those who test positive for genetic factors that put them at high risk for development of celiac disease (which the sponsors estimate at around 10%).

See the ClinicalTrials.gov website for full details and contact information.

Celiac Disease and the Purpose of the Study (As explained at ClinicalTrials.gov):

“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 diarrhea associated with growth disturbance in infancy historically characterized 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% to 2% in adult population.

"Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to various chronic symptoms like anemia, 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 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 counseling?

3. Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion?

"If we can confirm that optimizing the conditions at the introduction of wheat gluten in infancy diet significantly reduces the disease incidence, this will 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 organization of an adequate treatment."