ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Screen-detected Celiac Disease

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.
ClinicalTrials.gov Identifier: NCT01116505
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
Kalle Kurppa, Tampere University Hospital

May 3, 2010
May 5, 2010
August 27, 2012
August 2008
July 2012   (Final data collection date for primary outcome measure)
Small-bowel mucosal morphology and inflammation [ Time Frame: One year ]
Same as current
Complete list of historical versions of study NCT01116505 on ClinicalTrials.gov Archive Site
  • Endomysial antibodies [ Time Frame: one year ]
  • Tissue transglutaminase antibodies [ Time Frame: one year ]
  • Antibodies to deamidated gliadin [ Time Frame: one year ]
  • Intestinal tissue transglutaminase-specific IgA deposits [ Time Frame: one year ]
  • Bone mineral density [ Time Frame: one year ]
  • Body composition [ Time Frame: one year ]
  • Health-related quality of life [ Time Frame: one year ]
  • Laboratory parameters [ Time Frame: one year ]
  • Endomysial antibodies [ Time Frame: one year ]
  • Tissue transglutaminase antibodies [ Time Frame: one year ]
  • antibodies to deamitated gliadin [ Time Frame: one year ]
  • Intestinal tissue transglutaminase-specific IgA deposits [ Time Frame: one year ]
  • Bone mineral density [ Time Frame: one year ]
  • Body composition [ Time Frame: one year ]
  • Health-related quality of life [ Time Frame: one year ]
  • Laboratory parameters [ Time Frame: one year ]
Not Provided
Not Provided
 
Treatment of Screen-detected Celiac Disease
Treatment of Screen-detected Celiac Disease in Adults
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Celiac Disease
Dietary Supplement: Gluten-free diet
gluten-containing cereals removed from diet
  • No Intervention: gluten-containing diet
  • Active Comparator: Active comparator, gluten-free diet
    Intervention: Dietary Supplement: Gluten-free diet
Kurppa K, Paavola A, Collin P, Sievänen H, Laurila K, Huhtala H, Saavalainen P, Mäki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
August 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01116505
R07122
No
Not Provided
Not Provided
Kalle Kurppa, Tampere University Hospital
Tampere University Hospital
Not Provided
Principal Investigator: Katri Kaukinen, MD University of Tampere, Tampere University hospital
Tampere University Hospital
August 2012

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