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Treatment of Mild Enteropathy Celiac Disease (TMCD)

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
University Hospital
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00628823
First received: February 24, 2008
Last updated: December 3, 2008
Last verified: December 2008

February 24, 2008
December 3, 2008
March 2003
June 2008   (final data collection date for primary outcome measure)
Small-Bowel mucosal morphology [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628823 on ClinicalTrials.gov Archive Site
Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Mild Enteropathy Celiac Disease
Treatment of Mild Enteropathy Celiac Disease

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Celiac Disease
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
Other Name: No other names
  • No Intervention: A1
    Gluten-containing diet
  • Active Comparator: A2
    Gluten-free diet
    Intervention: Dietary Supplement: Gluten-free diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
December 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00628823
SA-115376
No
Katri Kaukinen MD, PhD, University of Tampere, Tampere University Hospital
University of Tampere
  • Academy of Finland
  • University Hospital
Principal Investigator: Katri Kaukinen, MD, PhD University of Tampere
University of Tampere
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP