Treatment of Mild Enteropathy Celiac Disease
- Conditions
- Celiac Disease
- Interventions
- Dietary Supplement: Gluten-free diet
- Registration Number
- NCT00628823
- Lead Sponsor
- Tampere University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Celiac disease suspicion
- Positive endomysial antibodies
- At least Marsh I -type small-bowel mucosal lesion
- Earlier celiac disease diagnosis
- Consuming oral corticosteroids or immune suppressants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 Gluten-free diet Gluten-free diet
- Primary Outcome Measures
Name Time Method Small-Bowel mucosal morphology one year
- Secondary Outcome Measures
Name Time Method Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. One year
Trial Locations
- Locations (1)
University of Tampere
🇫🇮Tampere, Finland