Treatment of Screen-detected Celiac Disease | NCT01116505

Studies
Treatment of Screen-detected Celiac Disease

NCT01116505

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Aug 27, 2012Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Celiac Disease

Interventions

Gluten-free diet

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 4, 2010

First Posted Date

May 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2012

Last Update Posted Date

Aug 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gluten-containing diet	No Intervention
Active comparator, gluten-free diet	Active Comparator		Dietary Supplement: Gluten-free diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten-free diet	Dietary Supplement	gluten-containing cereals removed from diet	Active comparator, gluten-free diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Small-bowel mucosal morphology and inflammation		One year

Secondary Outcomes

Measure	Description	Time Frame
Endomysial antibodies		one year
Tissue transglutaminase antibodies		one year
Antibodies to deamidated gliadin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katri Kaukinen, MD	University of Tampere, Tampere University hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Research Centre, Tampere University Hospital and University of Tampere		Tampere	Pirkanmaa	33014	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24837306	Derived	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.

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747