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Completed

NCT Number: NCT00628823

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tampere

Tampere, 33014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Dietary Supplement

Gluten containing foods removed from diet

Other names: No other names

Primary outcomes

  1. Small-Bowel mucosal morphology

    Time frame: one year

Secondary outcomes

  1. Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Academy of Finland
  • Tampere University

Registry information

Acronym: TMCD

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2008
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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