This trial is active, not recruiting.

Condition celiac disease
Treatment optimal gluten introduction
Sponsor Kuopio University Hospital
Collaborator University of Eastern Finland
Start date October 2007
End date August 2014
Trial size 168 participants
Trial identifier NCT00617838, KUH5021612


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
(Active Comparator)
Optimization of gluten introduction by nutritional councelling
optimal gluten introduction
Optimization of gluten introduction by nutritional counselling
(No Intervention)
No specific nutritional councelling. Follow-up of gluten introduction

Primary Outcomes

development of transglutaminase antibodies
time frame: 2-4 year age

Secondary Outcomes

gliadin peptide antibodies
time frame: 2-4 years
mucosal biopsy in TGA positive childre
time frame: 2-4 years

Eligibility Criteria

Male or female participants up to 2 months old.

Inclusion Criteria: - Presence of HLA-risk alleles DQA1*05 and DQB1*02 Exclusion Criteria: - Lack of these HLA risk alleles

Additional Information

Official title Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization
Principal investigator Jorma Ilonen, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.