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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. 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.
| Condition | Intervention |
|---|---|
|
Celiac Disease |
Dietary Supplement: Gluten-free diet |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Treatment of Mild Enteropathy Celiac Disease |
| Enrollment: | 73 |
| Study Start Date: | March 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A1: No Intervention
Gluten-containing diet
|
|
|
A2: Active Comparator
Gluten-free diet
|
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
|
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| Finland | |
| University of Tampere | |
| Tampere, Finland, 33014 | |
| 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 |
| Study First Received: | February 24, 2008 |
| Last Updated: | December 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00628823 History of Changes |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
|
Celiac Disease Endomysial antibodies Mild enteropathy Treatment Gluten-free diet |
|
Antibodies Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Intestinal Diseases Metabolic Disorder Immunoglobulins |
|
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases |
Malabsorption Syndromes Celiac Disease Intestinal Diseases |