Treatment of Screen-detected Celiac Disease

Celiac Disease Clinical Trial

Official title:

Treatment of Screen-detected Celiac Disease in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116505
• Other study ID #: R07122
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: August 24, 2012
• Start date: August 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Gluten-free diet
gluten-containing cereals removed from diet

Locations

Country	Name	City	State
Finland	Pediatric Research Centre, Tampere University Hospital and University of Tampere	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small-bowel mucosal morphology and inflammation		One year	No
Secondary	Endomysial antibodies		one year	No
Secondary	Tissue transglutaminase antibodies		one year	No
Secondary	Antibodies to deamidated gliadin		one year	No
Secondary	Intestinal tissue transglutaminase-specific IgA deposits		one year	No
Secondary	Bone mineral density		one year	No
Secondary	Body composition		one year	No
Secondary	Health-related quality of life		one year	No
Secondary	Laboratory parameters		one year	No