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Treatment of Mild Enteropathy Celiac Disease (TMCD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628823
First Posted: March 5, 2008
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Academy of Finland
University of Tampere
Information provided by (Responsible Party):
Kalle Kurppa, Tampere University Hospital
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Mild Enteropathy Celiac Disease

Resource links provided by NLM:


Further study details as provided by Kalle Kurppa, Tampere University Hospital:

Primary Outcome Measures:
  • Small-Bowel mucosal morphology [ Time Frame: one year ]

Secondary Outcome Measures:
  • Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. [ Time Frame: One year ]

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
No Intervention: A1
Gluten-containing diet
Active Comparator: A2
Gluten-free diet
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
Other Name: No other names

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628823


Locations
Finland
University of Tampere
Tampere, Finland, 33014
Sponsors and Collaborators
Tampere University Hospital
Academy of Finland
University of Tampere
Investigators
Principal Investigator: Katri Kaukinen, MD, PhD University of Tampere
  More Information

Responsible Party: Kalle Kurppa, MD., PhD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00628823     History of Changes
Other Study ID Numbers: SA-115376
First Submitted: February 24, 2008
First Posted: March 5, 2008
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Kalle Kurppa, Tampere University Hospital:
Celiac Disease
Endomysial antibodies
Mild enteropathy
Treatment
Gluten-free diet

Additional relevant MeSH terms:
Celiac Disease
Intestinal Diseases
Malabsorption Syndromes
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases