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Treatment of Screen-detected Celiac Disease

NCT ID: NCT01116505

Last Updated: 2012-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-08-31

Brief Summary

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The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

Detailed Description

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Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Conditions

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Celiac Disease

Keywords

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Celiac disease Endomysial antibodies Gluten-free diet Screen-detected Asymptomatic Bone mineral density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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gluten-containing diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Active comparator, gluten-free diet

Group Type ACTIVE_COMPARATOR

Gluten-free diet

Intervention Type DIETARY_SUPPLEMENT

gluten-containing cereals removed from diet

Interventions

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Gluten-free diet

gluten-containing cereals removed from diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Positive endomysial antibodies
* Adults

Exclusion Criteria

* Previous celiac disease diagnosis
* Significant clinical symptoms
* Suspicion of any serious celiac disease-associated complication
* Suspected or diagnosed severe illness other than celiac disease
* Consuming oral corticosteroids or immune suppressants
* Marked laboratory abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kalle Kurppa

M.D, Ph.D, Pediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katri Kaukinen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tampere, Tampere University hospital

Locations

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Pediatric Research Centre, Tampere University Hospital and University of Tampere

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

References

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Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.

Reference Type DERIVED
PMID: 24837306 (View on PubMed)

Other Identifiers

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R07122

Identifier Type: -

Identifier Source: org_study_id