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| Sponsors and Collaborators: |
University of Tampere Academy of Finland University Hospital |
| Information provided by: | University of Tampere |
| ClinicalTrials.gov Identifier: | NCT00628823 |
Purpose
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.
| Condition | Intervention |
|
Celiac Disease |
Dietary Supplement: Gluten-free diet |
| MedlinePlus related topics: | Celiac Disease |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Treatment of Mild Enteropathy Celiac Disease |
| Estimated Enrollment: | 75 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | May 2008 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A1: No Intervention
Gluten-containing diet
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A2: Active Comparator
Gluten-free diet
|
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
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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.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kalle Kurppa, MD | +358504372652 | kalle.kurppa@uta.fi |
| Finland | |||||
| University of Tampere | Recruiting | ||||
| Tampere, Finland, 33014 | |||||
| Contact: Kalle Kurppa, MD +358504372652 kalle.kurppa@uta.fi | |||||
| University of Tampere |
| Academy of Finland |
| University Hospital |
| Principal Investigator: | Katri Kaukinen, MD, PhD | University of Tampere |
| Principal Investigator: | Katri Kaukinen, MD, PhD | University of Tampere |
More Information
| Responsible Party: | University of Tampere, Tampere University Hospital ( Katri Kaukinen MD, PhD ) |
| Study ID Numbers: | SA-115376 |
| First Received: | February 24, 2008 |
| Last Updated: | February 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00628823 |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
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