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Treatment of Mild Enteropathy Celiac Disease (TMCD)

T

Tampere University Hospital

Status

Completed

Conditions

Celiac Disease

Treatments

Dietary Supplement: Gluten-free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00628823
SA-115376

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

16+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

73 participants in 2 patient groups

A1
No Intervention group
Description:
Gluten-containing diet
A2
Active Comparator group
Description:
Gluten-free diet
Treatment:
Dietary Supplement: Gluten-free diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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