Treatment of Mild Enteropathy Celiac Disease (TMCD)

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
University Hospital
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00628823
First received: February 24, 2008
Last updated: December 3, 2008
Last verified: December 2008
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Mild Enteropathy Celiac Disease

Resource links provided by NLM:


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
No Intervention: A1
Gluten-containing diet
Active Comparator: A2
Gluten-free diet
Dietary Supplement: Gluten-free diet
Gluten containing foods removed from diet
Other Name: No other names

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

Responsible Party: Katri Kaukinen MD, PhD, University of Tampere, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00628823     History of Changes
Other Study ID Numbers: SA-115376
Study First Received: February 24, 2008
Last Updated: December 3, 2008
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

Additional relevant MeSH terms:
Celiac Disease
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014