Clinical trial NCT01695681: Screen-detected Coeliac Disease, a Population Based Study
Official title: Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Quality of life
Celiac Disease/diet therapy
Celiac Disease/diagnosis
Prospective Studies
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Norwegian Coeliac Society
name: The Gastrointestinal Research Foundation, University Hospital of NorthNorway
First posted: 2012-09-28
Enrollment: 172
Sex: ALL
Minimum age (years): 30
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previously diagnosed coeliac disease

Primary outcomes:
measure: Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)
timeFrame: 7 days
Secondary outcomes:
measure: Quality of life score: Psychological General Well-Being Index (PGWBI)
timeFrame: 7 days
measure: Self-reported change in abdominal complaints
timeFrame: One year
measure: Self-reported change in energy
timeFrame: One year
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University hospital of North Norway
Study officials:
affiliation: University of Tromso
name: Jan- M Kvamme, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Trond Halstensen, MD PhD
role: STUDY_CHAIR
References:
citation: Kvamme JM, Sorbye S, Florholmen J, Halstensen TS. Population-based screening for celiac disease reveals that the majority of patients are undiagnosed and improve on a gluten-free diet. Sci Rep. 2022 Jul 25;12(1):12647. doi: 10.1038/s41598-022-16705-2.