Celiac DiseaseNCT01975155
Dietary Assessment and Mycotoxin Exposure in Celiac Disease
An observational study of Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- food questionnaire and Urinary mycotoxin test
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Jul 2016
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult subjects with or without celiac disease
Who may be able to join
- celiac disease diagnosis
- GFD for at least 2 years
Who cannot join
- follow a vegetarian diet
- being affected by important systemic or psychiatric disorders
- incapacity to fill the questionnaires
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Celiac Disease Center, Fondazione IRCCS Cà Granda
Milan, 20122
About this study
Official title: Dietary Assessment and Mycotoxin Exposure in Celiac Subjects
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.
Read the detailed description
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries, occurring in genetically susceptible individuals, elicited by the gluten ingestion. By definition the disease responds to gluten withdrawal, so currently gluten free (GFD) diet is the therapy for celiac patients. It is known that gluten rich products are important source of nutrients on the other hands it is not clear if gluten exclusion from the diet could have a negative effect on the nutritional status of CD patients.
Another concern related to the GFD could be the high exposure to mycotoxins due to the high concentration of maize in GF products.
AIM The aim of this study is to estimate the nutrient intake and the dietary exposure of all mycotoxin types in a group of treated celiac patients vs. non-celiac subjects.
METHODS We will enroll celiac patients and healthy controls. Exclusion criteria for celiac patients will be: 1) diagnosis of CD less than two years 2) age under 18 or over 70 3) associated metabolic or chronic disease 4) pregnancy or lactation 5) being vegetarian or vegan. Exclusion criteria for the healthy subjects will be the same with the exception of the diagnosis of CD.
Total food and beverage consumption will be assessed by means of a 7 days long questionnaire. All participants will be trained by a nutritionist to record all food consumed and the completed forms will be returned and reviewed during a face-to-face interview at which portions size were quantified in standard units. Participants will be asked to weigh all foods and drinks consumed and to provide a detailed description of each food, including methods of preparation and recipes, whenever possible. In case of Gluten Free Foods, patients will be asked to precisely note the name of the manufacturer or to provide the food label.
The nutrient intake was calculated using a software application linked to the food database of the European Institute of Oncology integrated with the nutrient composition of 60 commercial GF foods. The computer output will consist in the evaluation of the mean daily intake of macro nutrients for each subject, in terms of carbohydrates, protein and lipid. Food items consumed will be also collapsed into food categories; pasta, bread, potatoes, flours, different cereals, fruit, vegetables, milk, cheese, eggs, fish, oils and fats, biscuits, sweet snacks, breakfast cereals, candies, chocolate, soft drinks, juices, coffees, teas, alcoholic beverages. For each subject, the mean daily intake of each food category will be calculated.
The 24-h urines were collected at the end of the registration period and analyzed for mycotoxins.
- Conditions
- Celiac Disease
- Being tested
- food questionnaire, Urinary mycotoxin test
- Keywords
- Celiac disease, Gluten free diet nutrient content, mycotoxins, Gluten free diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food questionnaireOther
Urinary mycotoxin testOther
| Study group | Role | What they receive |
|---|---|---|
| Celiac | patients with celiac disease filling the questionnaire and undergoing urinary test Receives: Other: food questionnaire; Other: Urinary mycotoxin test | |
| healthy controls | healthy patients filling the questionnaire and undergoing urinary test Receives: Other: food questionnaire; Other: Urinary mycotoxin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycotoxins
Urinary measure of mycotoxins
Measured: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire
Secondary outcomes (1)
dietary questionnaire
during a 7 days lonf period the patients will be invited to fill a complete dietary questionnaire on the basis of the questionnaire results the nutritional status will be evaluated At the end of these 7 days the patients will collect the 24h urine for mycotoxin dosage
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma
- Responsible party
- Principal investigator, Leda Roncoroni, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Luca Elli, MD, Study chair, Celiac Disease Center, Fondazione IRCCS Cà GrandaNicoletta Pellegrini, Study chair, University of ParmaDario Conte, MD, Study chair, Celiac Disease Center, Fondazione IRCCS Cà Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975155
- Sponsor's protocol ID
- 852/12
- Other IDs
- GFD/2012
- Status last verified
- Aug 2015
- First submitted
- 23 Oct 2013
- Last updated
- 27 Aug 2015
- Results posted
- No
Publications
Morreale F, Agnoli C, Roncoroni L, Sieri S, Lombardo V, Mazzeo T, Elli L, Bardella MT, Agostoni C, Doneda L, Scricciolo A, Brighenti F, Pellegrini N. Are the dietary habits of treated individuals with celiac disease adherent to a Mediterranean diet? Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1148-1154. doi: 10.1016/j.numecd.2018.06.021. Epub 2018 Jul 4.
PubMed 30143412Mazzeo T, Roncoroni L, Lombardo V, Tomba C, Elli L, Sieri S, Grioni S, Bardella MT, Agostoni C, Doneda L, Brighenti F, Pellegrini N. Evaluation of a Modified Italian European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire for Individuals with Celiac Disease. J Acad Nutr Diet. 2016 Nov;116(11):1810-1816. doi: 10.1016/j.jand.2016.04.013. Epub 2016 May 28.
PubMed 27245762
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Assessment and Mycotoxin Exposure in Celiac Subjects
- ClinicalTrials.gov ID
- NCT01975155
- Acronym / sponsor ID
- 852/12
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Gluten free diet nutrient content, mycotoxins, Gluten free diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Parma
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Nov 2013 (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 (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.
Detailed description
Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries, occurring in genetically susceptible individuals, elicited by the gluten ingestion. By definition the disease responds to gluten withdrawal, so currently gluten free (GFD) diet is the therapy for celiac patients. It is known that gluten rich products are important source of nutrients on the other hands it is not clear if gluten exclusion from the diet could have a negative effect on the nutritional status of CD patients.
Another concern related to the GFD could be the high exposure to mycotoxins due to the high concentration of maize in GF products.
AIM The aim of this study is to estimate the nutrient intake and the dietary exposure of all mycotoxin types in a group of treated celiac patients vs. non-celiac subjects.
METHODS We will enroll celiac patients and healthy controls. Exclusion criteria for celiac patients will be: 1) diagnosis of CD less than two years 2) age under 18 or over 70 3) associated metabolic or chronic disease 4) pregnancy or lactation 5) being vegetarian or vegan. Exclusion criteria for the healthy subjects will be the same with the exception of the diagnosis of CD.
Total food and beverage consumption will be assessed by means of a 7 days long questionnaire. All participants will be trained by a nutritionist to record all food consumed and the completed forms will be returned and reviewed during a face-to-face interview at which portions size were quantified in standard units. Participants will be asked to weigh all foods and drinks consumed and to provide a detailed description of each food, including methods of preparation and recipes, whenever possible. In case of Gluten Free Foods, patients will be asked to precisely note the name of the manufacturer or to provide the food label.
The nutrient intake was calculated using a software application linked to the food database of the European Institute of Oncology integrated with the nutrient composition of 60 commercial GF foods. The computer output will consist in the evaluation of the mean daily intake of macro nutrients for each subject, in terms of carbohydrates, protein and lipid. Food items consumed will be also collapsed into food categories; pasta, bread, potatoes, flours, different cereals, fruit, vegetables, milk, cheese, eggs, fish, oils and fats, biscuits, sweet snacks, breakfast cereals, candies, chocolate, soft drinks, juices, coffees, teas, alcoholic beverages. For each subject, the mean daily intake of each food category will be calculated.
The 24-h urines were collected at the end of the registration period and analyzed for mycotoxins.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac | – | Other: food questionnaire, Other: Urinary mycotoxin testpatients with celiac disease filling the questionnaire and undergoing urinary test |
| healthy controls | – | Other: food questionnaire, Other: Urinary mycotoxin testhealthy patients filling the questionnaire and undergoing urinary test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult subjects with or without celiac disease
Key inclusion criteria (2 listed)
- celiac disease diagnosis
- GFD for at least 2 years
Key exclusion criteria (3 listed)
- follow a vegetarian diet
- being affected by important systemic or psychiatric disorders
- incapacity to fill the questionnaires
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 |
|---|---|---|
| food questionnaire | Other | Celiac, healthy controls |
| Urinary mycotoxin test | Other | Celiac, healthy controls |
Primary outcome
Mycotoxins
Time frame: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire
Urinary measure of mycotoxins
1 secondary outcome
dietary questionnaire
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Derived from this study: PubMed 30143412Morreale F, Agnoli C, Roncoroni L, Sieri S, Lombardo V, Mazzeo T, Elli L, Bardella MT, Agostoni C, Doneda L, Scricciolo A, Brighenti F, Pellegrini N. Are the dietary habits of treated individuals with celiac disease adherent to a Mediterranean diet? Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1148-1154. doi: 10.1016/j.numecd.2018.06.021. Epub 2018 Jul 4.
- Derived from this study: PubMed 27245762Mazzeo T, Roncoroni L, Lombardo V, Tomba C, Elli L, Sieri S, Grioni S, Bardella MT, Agostoni C, Doneda L, Brighenti F, Pellegrini N. Evaluation of a Modified Italian European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire for Individuals with Celiac Disease. J Acad Nutr Diet. 2016 Nov;116(11):1810-1816. doi: 10.1016/j.jand.2016.04.013. Epub 2016 May 28.
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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.
Luca Elli, MD study chair
Celiac Disease Center, Fondazione IRCCS Cà Granda
Nicoletta Pellegrini study chair
University of Parma
Dario Conte, MD study chair
Celiac Disease Center, Fondazione IRCCS Cà Granda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 2 inclusion and 3 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 27 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leda Roncooni (0039 02 55033384, leda.roncoroni@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycotoxins (time frame: mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire). 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 NCT01975155, which also lists 2 linked publications.
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 2015.