Celiac Disease Prevention

NCT00617838 | Unknown

• 1 other identifier: KUH5021612
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial cells and microvilli on gut mucosa is causing a "flat mucosa" and an absorption defect. The diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies to tissue transglutaminase and certain gliadin peptides are strongly associated with the pathology. Severe diarrhoea associated with growth disturbance in infancy was historically characterising the disease but is nowadays rare. Clinically more mild forms including silent disease are very common. Studies based on antibody screening and biopsies done in autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population. Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been recently found that undiagnosed celiac disease may be associated with general underachievement in society probably associated with common psychological symptoms like fatigue and depression during the adolescence. The disease is treated by complete elimination of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs in nutrition. Much progress has been recently made in understanding of the genetic background and immune markers associated with the disease as well as in understanding those patterns of gluten introduction in infancy, which might be connected to a high disease risk. Our aim in this study is in the first phase to identify children at high genetic risk (around 10%) and in a follow-up study to define:

1. 1.Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
2. 2.Is it possible to decrease the frequency of celiac disease by nutritional counselling?
3. 3.Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion

Conditions

Celiac Disease

Keywords

Celiac disease; genetic risk; gluten introduction; predicting antibodies

Outcome Measures

Primary Outcomes (1)

• development of transglutaminase antibodies

  2-4 year age

Secondary Outcomes (2)

• gliadin peptide antibodies

  2-4 years

• mucosal biopsy in TGA positive childre

  2-4 years

Study Arms (2)

1

ACTIVE COMPARATOR

Optimization of gluten introduction by nutritional councelling

Other: Optimal gluten introduction

2

NO INTERVENTION

No specific nutritional councelling. Follow-up of gluten introduction

Interventions

Optimal gluten introduction OTHER

Optimization of gluten introduction by nutritional counselling

1

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Presence of HLA-risk alleles DQA1\*05 and DQB1\*02

You may not qualify if:

• Lack of these HLA risk alleles

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator
• University of Turku: collaborator
• Finnish Institute for Health and Welfare: collaborator
• Päivikki and Sakari Sohlberg Foundation, Finland: collaborator
• Kätilöopisto Maternity Hospital: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, FIN-70211, Finland

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jorma Ilonen, MD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 23, 2013

Record last verified: 2013-08

Locations

FI (1)