Celiac Disease Prevention

Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization

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. 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. Is it possible to decrease the frequency of celiac disease by nutritional counselling?
3. Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion

If we can confirm, that optimising the conditions at the introduction of wheat gluten in infancy diet significantly reduces the disease incidence, will this have an important effect on the nutritional recommendations concerning the diet in infancy. Combining genetic screening and immunological tests might also offer a way to reduce the frequency of celiac disease and help in early diagnosis and organisation of an adequate treatment

Study Overview

• Status: Unknown
• Conditions: Celiac Disease
• Intervention / Treatment: Other: Optimal gluten introduction

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, FIN-70211
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Lack of these HLA risk alleles

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Optimization of gluten introduction by nutritional councelling	Other: Optimal gluten introduction; Optimization of gluten introduction by nutritional counselling
No Intervention: 2; No specific nutritional councelling. Follow-up of gluten introduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
development of transglutaminase antibodies	2-4 year age

Secondary Outcome Measures

Outcome Measure	Time Frame
gliadin peptide antibodies	2-4 years
mucosal biopsy in TGA positive childre	2-4 years

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Turku; University of Eastern Finland; Finnish Institute for Health and Welfare; Päivikki and Sakari Sohlberg Foundation, Finland; Kätilöopisto Maternity Hospital
• Investigators: Principal Investigator: Jorma Ilonen, MD, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 6, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: genetic risk; Celiac disease; gluten introduction; predicting antibodies
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: KUH5021612