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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Gluten-free diet | Gluten 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.