Pilot Study for the Evaluation of Food Choices in Patients With Inflammatory Bowel Diseases (MICI2021)
NCT ID: NCT05079932
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2021-04-01
2024-05-31
Brief Summary
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Detailed Description
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* Questionnaire on eating habits for the patient with IBD versus control patients;
* Modified Food Habits Frequency Questionnaire (FFQ), validated for the celiac population. The questionnaire assesses the extent, frequencies of consumption and quantity of gluten-containing foods in a year; this, in order to estimate the average introduction of gluten through the diet versus control patients;
* Anthropometric and plicometric analysis;
* Validated clinical activity questionnaires for RCU (ulcerative rectocolitis) and CD (Chron disease) (Mayo Score and Harvey-Bradshaw Index).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Gender: women and men
* Patients who have been diagnosed with IBD for at least 12 months
* patients who have signed an informed consent
Exclusion Criteria
* Patients not suffering from the two main forms of IBD, i.e. CD or RCU (unclassified IBD colitis, collagenous colitis, lymphocytic colitis will be excluded).
18 Years
ALL
Yes
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Luca Elli, MD, PhD
Principal Investigator
Principal Investigators
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Luca Elli, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Locations
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
Countries
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Central Contacts
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References
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Weaver KN, Herfarth H. Gluten-Free Diet in IBD: Time for a Recommendation? Mol Nutr Food Res. 2021 Mar;65(5):e1901274. doi: 10.1002/mnfr.201901274. Epub 2020 Jun 28.
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.
Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.
Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012 Nov;18(11):2056-62. doi: 10.1002/ibd.22879. Epub 2012 Jan 23.
Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.
Elli L, Bascunan K, di Lernia L, Bardella MT, Doneda L, Soldati L, Orlando S, Ferretti F, Lombardo V, Barigelletti G, Scricciolo A, Fabiano S, Vecchi M, Roncoroni L. Safety of occasional ingestion of gluten in patients with celiac disease: a real-life study. BMC Med. 2020 Mar 16;18(1):42. doi: 10.1186/s12916-020-1511-6.
Other Identifiers
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612_2021
Identifier Type: -
Identifier Source: org_study_id