Celiac Disease Prevention
Primary Purpose
Celiac Disease
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Optimal gluten introduction
Sponsored by
About this trial
This is an interventional prevention trial for Celiac Disease focused on measuring Celiac disease, genetic risk, gluten introduction, predicting antibodies
Eligibility Criteria
Inclusion Criteria:
- Presence of HLA-risk alleles DQA1*05 and DQB1*02
Exclusion Criteria:
- Lack of these HLA risk alleles
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Optimization of gluten introduction by nutritional councelling
No specific nutritional councelling. Follow-up of gluten introduction
Outcomes
Primary Outcome Measures
development of transglutaminase antibodies
Secondary Outcome Measures
gliadin peptide antibodies
mucosal biopsy in TGA positive childre
Full Information
NCT ID
NCT00617838
First Posted
February 6, 2008
Last Updated
August 22, 2013
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, University of Turku, Finnish Institute for Health and Welfare, Päivikki and Sakari Sohlberg Foundation, Finland, Kätilöopisto Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00617838
Brief Title
Celiac Disease Prevention
Official Title
Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, University of Turku, Finnish Institute for Health and Welfare, Päivikki and Sakari Sohlberg Foundation, Finland, Kätilöopisto Maternity Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
Is it possible to decrease the frequency of celiac disease by nutritional counselling?
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac disease, genetic risk, gluten introduction, predicting antibodies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Optimization of gluten introduction by nutritional councelling
Arm Title
2
Arm Type
No Intervention
Arm Description
No specific nutritional councelling. Follow-up of gluten introduction
Intervention Type
Other
Intervention Name(s)
Optimal gluten introduction
Intervention Description
Optimization of gluten introduction by nutritional counselling
Primary Outcome Measure Information:
Title
development of transglutaminase antibodies
Time Frame
2-4 year age
Secondary Outcome Measure Information:
Title
gliadin peptide antibodies
Time Frame
2-4 years
Title
mucosal biopsy in TGA positive childre
Time Frame
2-4 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of HLA-risk alleles DQA1*05 and DQB1*02
Exclusion Criteria:
Lack of these HLA risk alleles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorma Ilonen, MD
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Celiac Disease Prevention
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