Celiac Disease Prevention

Not Applicable

• Conditions: Celiac Disease
• Interventions: Other: Optimal gluten introduction

• Registration Number: NCT00617838
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23
• Primary Completion: 2014-08
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

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

Exclusion Criteria

• Lack of these HLA risk alleles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Optimal gluten introduction	Optimization of gluten introduction by nutritional councelling

Primary Outcome Measures

Name	Time	Method
development of transglutaminase antibodies	2-4 year age

Secondary Outcome Measures

Name	Time	Method
gliadin peptide antibodies	2-4 years
mucosal biopsy in TGA positive childre	2-4 years

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland