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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00628823
Other study ID # SA-115376
Secondary ID
Status Completed
Phase N/A
First received February 24, 2008
Last updated December 3, 2008
Start date March 2003
Est. completion date December 2008

Study information

Verified date December 2008
Source University of Tampere
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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Celiac disease suspicion

- Positive endomysial antibodies

- At least Marsh I -type small-bowel mucosal lesion

Exclusion Criteria:

- Earlier celiac disease diagnosis

- Consuming oral corticosteroids or immune suppressants

Study Design

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Gluten-free diet
Gluten containing foods removed from diet

Locations

Country Name City State
Finland University of Tampere Tampere

Sponsors (3)

Lead Sponsor Collaborator
University of Tampere Academy of Finland, University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Small-Bowel mucosal morphology one year No
Secondary Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. One year No
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