Treatment of Mild Enteropathy Celiac Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628823

Acronym

TMCD

Enrollment

Registered

2008-03-05

Start date

2003-03-31

Completion date

2008-12-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease, Endomysial antibodies, Mild enteropathy, Treatment, Gluten-free diet

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.

Interventions

DIETARY_SUPPLEMENTGluten-free diet

Gluten containing foods removed from diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Small-Bowel mucosal morphology	one year

Secondary

Measure	Time frame
Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.	One year

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026