Celiac DiseaseNCT01116505
Treatment of Screen-detected Celiac Disease
A study testing Gluten-free diet in people with Celiac Disease, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2008to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive endomysial antibodies
- Adults
Who cannot join
- Previous celiac disease diagnosis
- Significant clinical symptoms
- Suspicion of any serious celiac disease-associated complication
- Suspected or diagnosed severe illness other than celiac disease
- Consuming oral corticosteroids or immune suppressants
- Marked laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
Finland1 site
Pediatric Research Centre, Tampere University Hospital and University of Tampere
Tampere, Pirkanmaa, 33014
About this study
Official title: Treatment of Screen-detected Celiac Disease in Adults
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.
Read the detailed description
Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.
- Conditions
- Celiac Disease
- Being tested
- Gluten-free diet
- Keywords
- Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietDietary supplement
gluten-containing cereals removed from diet
| Study group | Role | What they receive |
|---|---|---|
| gluten-containing diet | No intervention | Not described |
| Active comparator, gluten-free diet | Active comparator | Not described Receives: Dietary Supplement: Gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small-bowel mucosal morphology and inflammation
Measured: One year
Secondary outcomes (8)
Endomysial antibodies
Measured: one year
Tissue transglutaminase antibodies
Measured: one year
Antibodies to deamidated gliadin
Measured: one year
Intestinal tissue transglutaminase-specific IgA deposits
Measured: one year
Bone mineral density
Measured: one year
Body composition
Measured: one year
Health-related quality of life
Measured: one year
Laboratory parameters
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startAug 2008
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kalle Kurppa, Tampere University Hospital
- Investigators
- Katri Kaukinen, MD, Principal investigator, University of Tampere, Tampere University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116505
- Sponsor's protocol ID
- R07122
- Status last verified
- Aug 2012
- First submitted
- 3 May 2010
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.
PubMed 24837306
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Screen-detected Celiac Disease in Adults
- ClinicalTrials.gov ID
- NCT01116505
- Acronym / sponsor ID
- R07122
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 May 2010 (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.
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.
Detailed description
Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gluten-containing diet | No intervention | – |
| Active comparator, gluten-free diet | Active comparator | Dietary Supplement: Gluten-free diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Positive endomysial antibodies
- Adults
Key exclusion criteria (6 listed)
- Previous celiac disease diagnosis
- Significant clinical symptoms
- Suspicion of any serious celiac disease-associated complication
- Suspected or diagnosed severe illness other than celiac disease
- Consuming oral corticosteroids or immune suppressants
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 |
|---|---|---|
| Gluten-free dietgluten-containing cereals removed from diet | Dietary supplement | Active comparator, gluten-free diet |
Primary outcome
Small-bowel mucosal morphology and inflammation
Time frame: One year
8 secondary outcomes
Endomysial antibodies
Time frame: one year
Tissue transglutaminase antibodies
Time frame: one year
Antibodies to deamidated gliadin
Time frame: one year
Intestinal tissue transglutaminase-specific IgA deposits
Time frame: one year
Bone mineral density
Time frame: one year
Body composition
Time frame: one year
Health-related quality of life
Time frame: one year
Laboratory parameters
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Derived from this study: PubMed 24837306Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
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.
Katri Kaukinen, MD principal investigator
University of Tampere, Tampere University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free diet in people with Celiac Disease, run by Tampere 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Small-bowel mucosal morphology and inflammation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116505, which also lists 1 linked publication.
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 27 Aug 2012.