Screen-detected Coeliac Disease, a Population Based Study

This study is currently recruiting participants.
Verified October 2012 by University Hospital of North Norway
Sponsor:
Collaborators:
The Norwegian Coeliac Society
The Gastrointestinal Research Foundation, University Hospital of NorthNorway
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01695681
First received: September 26, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to determine the prevalence of previously undiagnosed coeliac disease based on a health survey from Tromsø, Norway. Moreover, the health impact of undiagnosed coeliac disease will be examined.


Condition Intervention
Celiac Disease
Other: Gluten-free diet

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]
    Change in GSRS (Gastrointestinal symptoms rating scale) score at 1 year compared to baseline


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]
    Change in Quality of Life score (PGWBI - Psychological General Well-Being Index) at 1 year compared to baseline


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dietary instruction
Gluten-free diet
Other: Gluten-free diet
Dietary advice by clinical dietitian

Detailed Description:

Few population-based studies have examined the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed coeliac disease is much higher than the number who know their diagnosis.

The purpose of this study is to determine the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health.

In a health survey of the population of Tromsø Norway, serological markers of coeliac disease (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed. Individuals with increased level of one of these markers, will be invited for upper endoscopy with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons with screen detected coeliac disease, will be advised to start a gluten free diet.

Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.

  1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy verified coeliac disease and compared with a group of healthy control persons from the health-survey cohort.
  2. In a prospective study of the persons with screen detected coeliac disease, health status (GSRS) and Quality of Life will be compared before and after one year on a gluten free diet.
  Eligibility

Ages Eligible for Study:   30 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease

Exclusion Criteria:

  • Previously diagnosed coeliac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695681

Contacts
Contact: Jan- M Kvamme, MD, PhD 91507766 ext 47 jan.magnus.kvamme@unn.no
Contact: Jon R Florholmen, MD, PhD 91507766 ext 47 jon.florholmen@unn.no

Locations
Norway
University hospital of North Norway Recruiting
Tromsoe, Norway, 9038
Principal Investigator: Jan- M Kvamme, MD PhD         
Sponsors and Collaborators
University Hospital of North Norway
The Norwegian Coeliac Society
The Gastrointestinal Research Foundation, University Hospital of NorthNorway
Investigators
Principal Investigator: Jan- M Kvamme, MD PhD University of Tromso
Study Chair: Trond Halstensen, MD PhD University of Oslo
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01695681     History of Changes
Other Study ID Numbers: 2011/1943 (REK)
Study First Received: September 26, 2012
Last Updated: October 4, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University Hospital of North Norway:
Quality of life
Celiac Disease/diet therapy
Celiac Disease/diagnosis
Prospective Studies

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014