Treatment of Mild Enteropathy Celiac Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Mild Enteropathy Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Dietary Supplement: Gluten-free diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A1<br>Gluten-containing diet | |
| Active Comparator: A2<br>Gluten-free diet | Dietary Supplement: Gluten-free diet<br>* Gluten containing foods removed from diet<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small-Bowel mucosal morphology |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac Disease, Endomysial antibodies, Mild enteropathy, Treatment, Gluten-free diet