Clinical Trials Directory

Trials / Completed

CompletedNCT00628823

Treatment of Mild Enteropathy Celiac Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
73 (actual)
Sponsor
Tampere University Hospital · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

Detailed description

The current diagnostic criteria of celiac disease require small-bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). However, the mucosal damage develops gradually and the patients may have clinical symptoms and endomysial antibodies before the development of villous atrophy. The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. We hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTGluten-free dietGluten containing foods removed from diet

Timeline

Start date
2003-03-01
Primary completion
2008-06-01
Completion
2008-12-01
First posted
2008-03-05
Last updated
2016-05-17

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT00628823. Inclusion in this directory is not an endorsement.