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Treatment of Mild Enteropathy Celiac Disease (TMCD)

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 treatment trial for Celiac Disease focused on measuring Celiac Disease, Endomysial antibodies, Mild enteropathy, Treatment, Gluten-free diet

Eligibility Criteria

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

Inclusion Criteria:

  • Celiac disease suspicion
  • Positive endomysial antibodies
  • At least Marsh I -type small-bowel mucosal lesion

Exclusion Criteria:

  • Earlier celiac disease diagnosis
  • Consuming oral corticosteroids or immune suppressants

Sites / Locations

  • University of Tampere

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

A1

A2

Arm Description

Gluten-containing diet

Gluten-free diet

Outcomes

Primary Outcome Measures

Small-Bowel mucosal morphology

Secondary Outcome Measures

Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.

Full Information

First Posted
February 24, 2008
Last Updated
May 14, 2016
Sponsor
Tampere University Hospital
Collaborators
Academy of Finland, Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00628823
Brief Title
Treatment of Mild Enteropathy Celiac Disease
Acronym
TMCD
Official Title
Treatment of Mild Enteropathy Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.
Detailed Description
The current diagnostic criteria of celiac disease require small-bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). However, the mucosal damage develops gradually and the patients may have clinical symptoms and endomysial antibodies before the development of villous atrophy. The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. We hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

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, Mild enteropathy, Treatment, Gluten-free diet

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
No Intervention
Arm Description
Gluten-containing diet
Arm Title
A2
Arm Type
Active Comparator
Arm Description
Gluten-free diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Other Intervention Name(s)
No other names
Intervention Description
Gluten containing foods removed from diet
Primary Outcome Measure Information:
Title
Small-Bowel mucosal morphology
Time Frame
one year
Secondary Outcome Measure Information:
Title
Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Celiac disease suspicion Positive endomysial antibodies At least Marsh I -type small-bowel mucosal lesion Exclusion Criteria: Earlier celiac disease diagnosis Consuming oral corticosteroids or immune suppressants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katri Kaukinen, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tampere
City
Tampere
ZIP/Postal Code
33014
Country
Finland

12. IPD Sharing Statement

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Treatment of Mild Enteropathy Celiac Disease

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