Treatment of Mild Enteropathy Celiac Disease - Full Text View

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. 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.

Condition	Intervention
Celiac Disease	Dietary Supplement: Gluten-free diet

MedlinePlus related topics:

Celiac Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Official Title:	Treatment of Mild Enteropathy Celiac Disease

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 ]

Estimated Enrollment:	75
Study Start Date:	March 2003
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 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

Contacts


Contact: Kalle Kurppa, MD	+358504372652	kalle.kurppa@uta.fi

Locations


Finland
	University of Tampere	Recruiting
	Tampere, Finland, 33014
	Contact: Kalle Kurppa, MD +358504372652 kalle.kurppa@uta.fi

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

Responsible Party:	University of Tampere, Tampere University Hospital ( Katri Kaukinen MD, PhD )
Study ID Numbers:	SA-115376
First Received:	February 24, 2008
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00628823
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

Metabolic disorder

Intestinal Diseases

ClinicalTrials.gov processed this record on August 29, 2008

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