NCT01116505

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

3.9 years

First QC Date

May 3, 2010

Last Update Submit

August 24, 2012

Conditions

Celiac Disease

Keywords

Celiac diseaseEndomysial antibodiesGluten-free dietScreen-detectedAsymptomaticBone mineral density

Outcome Measures

Primary Outcomes (1)

  • Small-bowel mucosal morphology and inflammation

    One year

Secondary Outcomes (8)

  • Endomysial antibodies

    one year

  • Tissue transglutaminase antibodies

    one year

  • Antibodies to deamidated gliadin

    one year

  • Intestinal tissue transglutaminase-specific IgA deposits

    one year

  • Bone mineral density

    one year

  • +3 more secondary outcomes

Study Arms (2)

gluten-containing diet

NO INTERVENTION

Active comparator, gluten-free diet

ACTIVE COMPARATOR
Dietary Supplement: Gluten-free diet

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

gluten-containing cereals removed from diet

Active comparator, gluten-free diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive endomysial antibodies
  • Adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Research Centre, Tampere University Hospital and University of Tampere

Tampere, Pirkanmaa, 33014, Finland

Location

Related Publications (1)

  • 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.

    PMID: 24837306DERIVED

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

    University of Tampere, Tampere University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D, Pediatrician

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

August 1, 2008

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

FI(1)