Screen-detected Coeliac Disease, a Population Based Study
Primary Purpose
Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
About this trial
This is an interventional diagnostic trial for Celiac Disease focused on measuring Quality of life, Celiac Disease/diet therapy, Celiac Disease/diagnosis, Prospective Studies
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
Sites / Locations
- University hospital of North Norway
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dietary instruction
Arm Description
Gluten-free diet
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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"
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"
Full Information
NCT ID
NCT01695681
First Posted
September 26, 2012
Last Updated
March 9, 2020
Sponsor
University Hospital of North Norway
Collaborators
The Norwegian Coeliac Society, The Gastrointestinal Research Foundation, University Hospital of NorthNorway
1. Study Identification
Unique Protocol Identification Number
NCT01695681
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
April 15, 2015 (Actual)
Study Completion Date
April 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
The Norwegian Coeliac Society, The Gastrointestinal Research Foundation, University Hospital of NorthNorway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Quality of life, Celiac Disease/diet therapy, Celiac Disease/diagnosis, Prospective Studies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary instruction
Arm Type
Other
Arm Description
Gluten-free diet
Intervention Type
Other
Intervention Name(s)
Gluten-free diet
Intervention Description
Dietary advice by clinical dietitian
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)
Description
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)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Quality of life score: Psychological General Well-Being Index (PGWBI)
Description
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)
Time Frame
7 days
Title
Self-reported change in abdominal complaints
Description
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"
Time Frame
One year
Title
Self-reported change in energy
Description
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"
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan- M Kvamme, MD PhD
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trond Halstensen, MD PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
University hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
35879335
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.
Results Reference
derived
Learn more about this trial
Screen-detected Coeliac Disease, a Population Based Study
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