Treatment of Screen-detected Celiac Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kalle Kurppa, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01116505
First received: May 3, 2010
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Celiac Disease
Dietary Supplement: Gluten-free diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Treatment of Screen-detected Celiac Disease in Adults

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Small-bowel mucosal morphology and inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endomysial antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Tissue transglutaminase antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Antibodies to deamidated gliadin [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Intestinal tissue transglutaminase-specific IgA deposits [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Laboratory parameters [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: gluten-containing diet
Active Comparator: Active comparator, gluten-free diet Dietary Supplement: Gluten-free diet
gluten-containing cereals removed from diet

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116505

Locations
Finland
Pediatric Research Centre, Tampere University Hospital and University of Tampere
Tampere, Pirkanmaa, Finland, 33014
Sponsors and Collaborators
Tampere University Hospital
Investigators
Principal Investigator: Katri Kaukinen, MD University of Tampere, Tampere University hospital
  More Information

No publications provided

Responsible Party: Kalle Kurppa, M.D, Ph.D, Pediatrician, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01116505     History of Changes
Other Study ID Numbers: R07122
Study First Received: May 3, 2010
Last Updated: August 24, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Tampere University Hospital:
Celiac disease
Endomysial antibodies
Gluten-free diet
Screen-detected
Asymptomatic
Bone mineral density

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

ClinicalTrials.gov processed this record on April 21, 2014