Treatment of Screen-detected Celiac Disease

August 24, 2012 updated by: Kalle Kurppa, Tampere University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33014
        • Pediatric Research Centre, Tampere University Hospital and University of Tampere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: gluten-containing diet
Active Comparator: Active comparator, gluten-free diet
Dietary supplement: Gluten-free diet
gluten-containing cereals removed from diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Small-bowel mucosal morphology and inflammation
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Endomysial antibodies
Time Frame: one year
one year
Tissue transglutaminase antibodies
Time Frame: one year
one year
Antibodies to deamidated gliadin
Time Frame: one year
one year
Intestinal tissue transglutaminase-specific IgA deposits
Time Frame: one year
one year
Bone mineral density
Time Frame: one year
one year
Body composition
Time Frame: one year
one year
Health-related quality of life
Time Frame: one year
one year
Laboratory parameters
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Katri Kaukinen, MD, University of Tampere, Tampere University hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R07122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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