NCT00628823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

5.3 years

First QC Date

February 24, 2008

Last Update Submit

May 14, 2016

Conditions

Celiac Disease

Keywords

Celiac DiseaseEndomysial antibodiesMild enteropathyTreatmentGluten-free diet

Outcome Measures

Primary Outcomes (1)

  • Small-Bowel mucosal morphology

    one year

Secondary Outcomes (1)

  • Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.

    One year

Study Arms (2)

A1

NO INTERVENTION

Gluten-containing diet

A2

ACTIVE COMPARATOR

Gluten-free diet

Dietary Supplement: Gluten-free diet

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

Gluten containing foods removed from diet

Also known as: No other names
A2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Celiac disease suspicion
  • Positive endomysial antibodies
  • At least Marsh I -type small-bowel mucosal lesion

You may not qualify if:

  • Earlier celiac disease diagnosis
  • Consuming oral corticosteroids or immune suppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tampere

Tampere, 33014, Finland

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Katri Kaukinen, MD, PhD

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., PhD

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 5, 2008

Study Start

March 1, 2003

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

FI(1)