An interventional study of Gluten-free diet in Celiac Disease, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Diagnostic
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.
Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Gluten-free diet
gluten-containing cereals removed from diet
Small-bowel mucosal morphology and inflammation
Time frame: One year
Endomysial antibodies
Time frame: one year
Tissue transglutaminase antibodies
Time frame: one year
Antibodies to deamidated gliadin
Time frame: one year
Intestinal tissue transglutaminase-specific IgA deposits
Time frame: one year
Bone mineral density
Time frame: one year
Body composition
Time frame: one year
Health-related quality of life
Time frame: one year
Laboratory parameters
Time frame: one year
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital