Treatment of Screen-detected Celiac Disease

Not Applicable

Completed

• Conditions: Celiac Disease
• Interventions: Dietary Supplement: Gluten-free diet

• Registration Number: NCT01116505
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active comparator, gluten-free diet	Gluten-free diet	-

Primary Outcome Measures

Name	Time	Method
Small-bowel mucosal morphology and inflammation	One year

Secondary Outcome Measures

Name	Time	Method
Endomysial antibodies	one year
Tissue transglutaminase antibodies	one year
Antibodies to deamidated gliadin	one year
Intestinal tissue transglutaminase-specific IgA deposits	one year
Bone mineral density	one year
Body composition	one year
Health-related quality of life	one year
Laboratory parameters	one year

Trial Locations

Locations (1)

Pediatric Research Centre, Tampere University Hospital and University of Tampere; 🇫🇮 Tampere, Pirkanmaa, Finland