NCT01975155

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

October 23, 2013

Last Update Submit

August 26, 2015

Conditions

Celiac Disease

Keywords

Celiac diseaseGluten free diet nutrient contentmycotoxinsGluten free diet

Outcome Measures

Primary Outcomes (1)

  • Mycotoxins

    Urinary measure of mycotoxins

    mycotoxins will be measured at the end of a 7 day period and the completion of the dietary questionnaire

Secondary Outcomes (1)

  • dietary questionnaire

    7 days

Study Arms (2)

Celiac

patients with celiac disease filling the questionnaire and undergoing urinary test

Other: food questionnaireOther: Urinary mycotoxin test

healthy controls

healthy patients filling the questionnaire and undergoing urinary test

Other: food questionnaireOther: Urinary mycotoxin test

Interventions

food questionnaireOTHER
Celiachealthy controls
Urinary mycotoxin testOTHER
Celiachealthy controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult subjects with or without celiac disease

You may qualify if:

  • celiac disease diagnosis
  • GFD for at least 2 years

You may not qualify if:

  • follow a vegetarian diet
  • being affected by important systemic or psychiatric disorders
  • incapacity to fill the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celiac Disease Center, Fondazione IRCCS Cà Granda

Milan, 20122, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30143412DERIVED

  • Mazzeo 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.

    PMID: 27245762DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Luca Elli, MD

    Celiac Disease Center, Fondazione IRCCS Cà Granda

    STUDY CHAIR

  • Nicoletta Pellegrini

    University of Parma

    STUDY CHAIR

  • Dario Conte, MD

    Celiac Disease Center, Fondazione IRCCS Cà Granda

    STUDY CHAIR

Central Study Contacts

Leda Roncooni

CONTACT

0039 02 55033384leda.roncoroni@tiscali.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biologist

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

IT(1)