Celiac Disease Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Eastern Finland
University of Turku
National Institute for Health and Welfare, Finland
Päivikki and Sakari Sohlberg Foundation, Finland
Kätilöopisto Maternity Hospital
Information provided by (Responsible Party):
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00617838
First received: February 6, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Celiac Disease
Other: Optimal gluten introduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • development of transglutaminase antibodies [ Time Frame: 2-4 year age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gliadin peptide antibodies [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]
  • mucosal biopsy in TGA positive childre [ Time Frame: 2-4 years ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of these HLA risk alleles
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617838

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, FIN-70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
University of Turku
National Institute for Health and Welfare, Finland
Päivikki and Sakari Sohlberg Foundation, Finland
Kätilöopisto Maternity Hospital
Investigators
Principal Investigator: Jorma Ilonen, MD University of Eastern Finland
  More Information

No publications provided

Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00617838     History of Changes
Other Study ID Numbers: KUH5021612
Study First Received: February 6, 2008
Last Updated: August 22, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:
Celiac disease
genetic risk
gluten introduction
predicting antibodies

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014