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NCT Number: NCT01695681

Screen-detected Coeliac Disease, a Population Based Study

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Disease Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of North Norway

Tromsø, 9038, Norway

About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previously diagnosed coeliac disease

Treatment and study plan

Gluten-free diet

Other

Dietary advice by clinical dietitian

Primary outcomes

  1. Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)

    Time frame: 7 days

    The Gastrointestinal symptoms rating scale (GSRS) is a disease-specific instrument with 15 items combined into five major domains: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation.

    The scale assesses symptom severity using a seven-grade Likert scale, ranging from 1 (no discomfort at all) to 7 (very severe discomfort). A lower score indicates less symptoms.

    GSRS is obtained at first visit and at follow-up (>one year) to evaluate change in one of the five domain scores or total score (primary outcome)

Secondary outcomes

  1. Quality of life score: Psychological General Well-Being Index (PGWBI)

    Time frame: 7 days

    The Psychological General Well-Being Index (PGWBI) is a generic instrument with 22 items combined into six major domains: Anxiety, Depressed Mode, Positive well-being, Self-control, General Health and Vitality

    The scale assesses symptom severity from 0 to 5. Higher score indicates a better psychological well being.

    PGWB is obtained at first visit and at follow-up (>one year) to evaluate change in one of the six domains or total score (secondary outcome)

  2. Self-reported change in abdominal complaints

    Time frame: One year

    Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about abdominal complaints after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from "very much worse" to "very much better"

  3. Self-reported change in energy

    Time frame: One year

    Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about energy/feeling-fit after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from "very much worse" to "very much better"

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • The Gastrointestinal Research Foundation, University Hospital of NorthNorway
  • The Norwegian Coeliac Society

Registry information

Official study title

Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2012
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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