Celiac DiseaseNCT00617838
Celiac Disease Prevention
A study testing Optimal gluten introduction in people with Celiac Disease, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Optimal gluten introduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2007to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Presence of HLA-risk alleles DQA1*05 and DQB1*02
Who cannot join
- Lack of these HLA risk alleles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
- Is it possible to decrease the frequency of celiac disease by nutritional counselling?
- 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
- Conditions
- Celiac Disease
- Being tested
- Optimal gluten introduction
- Keywords
- Celiac disease, genetic risk, gluten introduction, predicting antibodies
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal gluten introductionOther
Optimization of gluten introduction by nutritional counselling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Optimization of gluten introduction by nutritional councelling Receives: Other: Optimal gluten introduction |
| 2 | No intervention | No specific nutritional councelling. Follow-up of gluten introduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of transglutaminase antibodies
Measured: 2-4 year age
Secondary outcomes (2)
gliadin peptide antibodies
Measured: 2-4 years
mucosal biopsy in TGA positive childre
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, University of Turku, Finnish Institute for Health and Welfare, Päivikki and Sakari Sohlberg Foundation, Finland, Kätilöopisto Maternity Hospital
- Responsible party
- Sponsor
- Investigators
- Jorma Ilonen, MD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617838
- Sponsor's protocol ID
- KUH5021612
- Status last verified
- Aug 2013
- First submitted
- 6 Feb 2008
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Celiac Disease in Children at Genetic Risk - Optimized Introduction of Gluten and Follow-up of Immunization
- ClinicalTrials.gov ID
- NCT00617838
- Acronym / sponsor ID
- KUH5021612
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, genetic risk, gluten introduction, predicting antibodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, University of Turku, Finnish Institute for Health and Welfare, Päivikki and Sakari Sohlberg Foundation, Finland, Kätilöopisto Maternity Hospital
- Study start
- Oct 2007
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease?
- Is it possible to decrease the frequency of celiac disease by nutritional counselling?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Optimal gluten introductionOptimization of gluten introduction by nutritional councelling |
| 2 | No intervention | –No specific nutritional councelling. Follow-up of gluten introduction |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presence of HLA-risk alleles DQA1*05 and DQB1*02
Key exclusion criteria (1 listed)
- Lack of these HLA risk alleles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal gluten introductionOptimization of gluten introduction by nutritional counselling | Other | 1 |
Primary outcome
development of transglutaminase antibodies
Time frame: 2-4 year age
2 secondary outcomes
gliadin peptide antibodies
Time frame: 2-4 years
mucosal biopsy in TGA positive childre
Time frame: 2-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
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GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorma Ilonen, MD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal gluten introduction in people with Celiac Disease, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of transglutaminase antibodies (time frame: 2-4 year age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.