An interventional study of Gluten-free diet in Celiac Disease, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
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.
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.
332 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's enrollment of 73 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Gluten-containing diet
Gluten-free diet
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
Also known as: No other names
Small-Bowel mucosal morphology
Time frame: one year
Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.
Time frame: One year
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital