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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

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

Condition or disease Intervention/treatment Phase
Celiac Disease Other: Optimal gluten introduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization
Study Start Date : October 2007
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Active Comparator: 1
Optimization of gluten introduction by nutritional councelling
Other: Optimal gluten introduction
Optimization of gluten introduction by nutritional counselling

No Intervention: 2
No specific nutritional councelling. Follow-up of gluten introduction

Primary Outcome Measures :
  1. development of transglutaminase antibodies [ Time Frame: 2-4 year age ]

Secondary Outcome Measures :
  1. gliadin peptide antibodies [ Time Frame: 2-4 years ]
  2. mucosal biopsy in TGA positive childre [ Time Frame: 2-4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of these HLA risk alleles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00617838

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Kuopio University Hospital
Kuopio, Finland, FIN-70211
Sponsors and Collaborators
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
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Principal Investigator: Jorma Ilonen, MD University of Eastern Finland

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Responsible Party: Kuopio University Hospital Identifier: NCT00617838    
Other Study ID Numbers: KUH5021612
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013
Keywords provided by Kuopio University Hospital:
Celiac disease
genetic risk
gluten introduction
predicting antibodies
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases