Screen-detected Coeliac Disease, a Population Based Study

NCT01695681 | Completed

• 1 other identifier: 2011/1943 (REK)
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Quality of life; Celiac Disease/diet therapy; Celiac Disease/diagnosis; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  7 days

• Self-reported change in abdominal complaints

  One year

• Self-reported change in energy

  One year

Study Arms (1)

Dietary instruction

OTHER

Gluten-free diet

Other: Gluten-free diet

Interventions

Gluten-free diet OTHER

Dietary advice by clinical dietitian

Dietary instruction

Eligibility Criteria

• Age: 30 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previously diagnosed coeliac disease

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Norwegian Coeliac Society: collaborator
• The Gastrointestinal Research Foundation, University Hospital of NorthNorway: collaborator

Study Sites (1)

University hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

• 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.

  PMID: 35879335 DERIVED

MeSH Terms

Conditions

Celiac Disease; Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jan- M Kvamme, MD PhD

  University of Tromso

  PRINCIPAL INVESTIGATOR

• Trond Halstensen, MD PhD

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: October 1, 2012
• Primary Completion: April 15, 2015
• Study Completion: April 15, 2015
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

NO (1)