Celiac Disease
Conditions
Keywords
Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGluten-free diet
gluten-containing cereals removed from diet
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Positive endomysial antibodies * Adults
Exclusion criteria
* Previous celiac disease diagnosis * Significant clinical symptoms * Suspicion of any serious celiac disease-associated complication * Suspected or diagnosed severe illness other than celiac disease * Consuming oral corticosteroids or immune suppressants * Marked laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Small-bowel mucosal morphology and inflammation | One year |
Secondary
| Measure | Time frame |
|---|---|
| Tissue transglutaminase antibodies | one year |
| Antibodies to deamidated gliadin | one year |
| Intestinal tissue transglutaminase-specific IgA deposits | one year |
| Endomysial antibodies | one year |
| Body composition | one year |
| Health-related quality of life | one year |
| Laboratory parameters | one year |
| Bone mineral density | one year |
Countries
Finland
Outcome results
None listed