Treatment of Mild Enteropathy Celiac Disease - Full Text View

Sponsors and Collaborators:	University of Tampere Academy of Finland University Hospital
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00628823

Purpose

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.

Condition	Intervention
Celiac Disease	Dietary Supplement: Gluten-free diet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Treatment of Mild Enteropathy Celiac Disease

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease Diets

U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:

Small-Bowel mucosal morphology [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	March 2003
Study Completion Date:	December 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: No Intervention Gluten-containing diet
A2: Active Comparator Gluten-free diet	Dietary Supplement: Gluten-free diet Gluten containing foods removed from diet

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628823

Locations

Finland
University of Tampere
Tampere, Finland, 33014

Sponsors and Collaborators

University of Tampere

Academy of Finland

University Hospital

Investigators

Principal Investigator:	Katri Kaukinen, MD, PhD	University of Tampere
Principal Investigator:	Katri Kaukinen, MD, PhD	University of Tampere

More Information

No publications provided

Responsible Party:	University of Tampere, Tampere University Hospital ( Katri Kaukinen MD, PhD )
Study ID Numbers:	SA-115376
Study First Received:	February 24, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00628823 History of Changes
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by University of Tampere:

Celiac Disease
Endomysial antibodies
Mild enteropathy
Treatment
Gluten-free diet

Study placed in the following topic categories:

Antibodies
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes

Celiac Disease
Intestinal Diseases
Metabolic Disorder
Immunoglobulins

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases

Malabsorption Syndromes
Celiac Disease
Intestinal Diseases

ClinicalTrials.gov processed this record on July 02, 2009