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Completed

NCT Number: NCT01116505

Treatment of Screen-detected Celiac Disease

The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Research Centre, Tampere University Hospital and University of Tampere

Tampere, Pirkanmaa, 33014, Finland

About this study

Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive endomysial antibodies
  • Adults

Exclusion criteria

  • Previous celiac disease diagnosis
  • Significant clinical symptoms
  • Suspicion of any serious celiac disease-associated complication
  • Suspected or diagnosed severe illness other than celiac disease
  • Consuming oral corticosteroids or immune suppressants
  • Marked laboratory abnormalities

Treatment and study plan

Gluten-free diet

Dietary Supplement

gluten-containing cereals removed from diet

Primary outcomes

  1. Small-bowel mucosal morphology and inflammation

    Time frame: One year

Secondary outcomes

  1. Endomysial antibodies

    Time frame: one year

  2. Tissue transglutaminase antibodies

    Time frame: one year

  3. Antibodies to deamidated gliadin

    Time frame: one year

  4. Intestinal tissue transglutaminase-specific IgA deposits

    Time frame: one year

  5. Bone mineral density

    Time frame: one year

  6. Body composition

    Time frame: one year

  7. Health-related quality of life

    Time frame: one year

  8. Laboratory parameters

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Treatment of Screen-detected Celiac Disease in Adults

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 5, 2010
Registry last updated
Aug 27, 2012

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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