Celiac DiseaseNCT00250146
Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease
A study testing Gluten (behaviour) in people with Celiac Disease, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten. 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 (behaviour)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2001to Mar 2005
- 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
- adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -
Who cannot join
- patients younger than 18 years old;
- poor compliance to the gluten-free diet;
- abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
- associated conditions, such as selective IgA deficiency or other autoimmune diseases -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.
Read the detailed description
Treatment of celiac disease (CD) is based on the complete avoidance of gluten-containing products in the diet. However it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment. This is an important issue, as even a strict gluten-free diet (GFD) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients. This is a prospective, placebo-controlled, double-blind study. Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years. During the study period their background daily gluten intake is kept lower than 5 mg. After baseline evaluation, patients continue their GFD and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. The following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.
- Conditions
- Celiac Disease
- Being tested
- Gluten (behaviour)
- Keywords
- Celiac Disease, Gluten, Toxicity, Small bowel morphometry
- 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 (behaviour)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Villous Height/Crypt Depth ratio on small intestinal biopsy
Intraepithelial lymphocyte coun on small intestinal biopsy
changes in serum IgA class anti-trasnglutaminase antibodies
changes in serum IgG class anti-gliadin antibodies
clinical symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startFeb 2001
- Study completionMar 2005
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Celiachia (AIC)
- Investigators
- Carlo Catassi, M.D., Principal investigator, Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250146
- Sponsor's protocol ID
- IRB-2000-611
- Status last verified
- Apr 2005
- First submitted
- 3 Nov 2005
- Last updated
- 7 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease
- ClinicalTrials.gov ID
- NCT00250146
- Acronym / sponsor ID
- IRB-2000-611
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Gluten, Toxicity, Small bowel morphometry
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Collaborators
- Associazione Italiana Celiachia (AIC)
- Study start
- Feb 2001
- Study completion
- Mar 2005
- First posted
- 7 Nov 2005 (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 purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.
Detailed description
Treatment of celiac disease (CD) is based on the complete avoidance of gluten-containing products in the diet. However it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment. This is an important issue, as even a strict gluten-free diet (GFD) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients. This is a prospective, placebo-controlled, double-blind study. Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years. During the study period their background daily gluten intake is kept lower than 5 mg. After baseline evaluation, patients continue their GFD and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. The following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -
Key exclusion criteria (4 listed)
- patients younger than 18 years old;
- poor compliance to the gluten-free diet;
- abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
- associated conditions, such as selective IgA deficiency or other autoimmune diseases -
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 (behaviour) | Behavioural | – |
Primary outcome
Villous Height/Crypt Depth ratio on small intestinal biopsy
Intraepithelial lymphocyte coun on small intestinal biopsy
changes in serum IgA class anti-trasnglutaminase antibodies
changes in serum IgG class anti-gliadin antibodies
clinical symptoms
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2005.
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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.
Carlo Catassi, M.D. principal investigator
Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy
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 (behaviour) in people with Celiac Disease, run by Università Politecnica delle Marche at 1 site in Italy.
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 4 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: stopped early, as of the sponsor's last update on 7 Nov 2005. 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 Italy. 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 was stopped early. 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?
Villous Height/Crypt Depth ratio on small intestinal biopsy. The study lists 5 primary outcomes in all. 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 7 Nov 2005.