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Treatment of Screen-detected Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Celiac Disease focused on measuring Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Research Centre, Tampere University Hospital and University of Tampere

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

gluten-containing diet

Active comparator, gluten-free diet

Arm Description

Outcomes

Primary Outcome Measures

Small-bowel mucosal morphology and inflammation

Secondary Outcome Measures

Endomysial antibodies
Tissue transglutaminase antibodies
Antibodies to deamidated gliadin
Intestinal tissue transglutaminase-specific IgA deposits
Bone mineral density
Body composition
Health-related quality of life
Laboratory parameters

Full Information

First Posted
May 3, 2010
Last Updated
August 24, 2012
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01116505
Brief Title
Treatment of Screen-detected Celiac Disease
Official Title
Treatment of Screen-detected Celiac Disease in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gluten-containing diet
Arm Type
No Intervention
Arm Title
Active comparator, gluten-free diet
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Intervention Description
gluten-containing cereals removed from diet
Primary Outcome Measure Information:
Title
Small-bowel mucosal morphology and inflammation
Time Frame
One year
Secondary Outcome Measure Information:
Title
Endomysial antibodies
Time Frame
one year
Title
Tissue transglutaminase antibodies
Time Frame
one year
Title
Antibodies to deamidated gliadin
Time Frame
one year
Title
Intestinal tissue transglutaminase-specific IgA deposits
Time Frame
one year
Title
Bone mineral density
Time Frame
one year
Title
Body composition
Time Frame
one year
Title
Health-related quality of life
Time Frame
one year
Title
Laboratory parameters
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katri Kaukinen, MD
Organizational Affiliation
University of Tampere, Tampere University hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Research Centre, Tampere University Hospital and University of Tampere
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33014
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24837306
Citation
Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki 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.
Results Reference
derived

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Treatment of Screen-detected Celiac Disease

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