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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014