Treatment of Screen-detected Celiac Disease

Tampere University Hospital

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: Gluten-free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01116505

R07122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

gluten-containing diet

No Intervention group

Active comparator, gluten-free diet

Active Comparator group

Treatment:

Dietary Supplement: Gluten-free diet