Screen-detected Coeliac Disease, a Population Based Study

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695681
• Other study ID #: 2011/1943 (REK)
• Status: Completed
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: April 15, 2015

Study information

• Verified date: March 2020
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 15, 2015
• Est. primary completion date: April 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 87 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previously diagnosed coeliac disease

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Other:
• Gluten-free diet
Dietary advice by clinical dietitian

Locations

Country	Name	City	State
Norway	University hospital of North Norway	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	The Gastrointestinal Research Foundation, University Hospital of NorthNorway, The Norwegian Coeliac Society

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)	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)	7 days
Secondary	Quality of life score: Psychological General Well-Being Index (PGWBI)	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)	7 days
Secondary	Self-reported change in abdominal complaints	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"	One year
Secondary	Self-reported change in energy	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"	One year