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This project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with IBD compared to a control population. The aim of the study is to evaluate for the first time in an Italian population of subjects with IBD the presence of a diet based on GFD (gluten free diet).
Subjects with IBD will be recruited among the patients referred to the IBD clinic of the Policlinico of Milan. These patients are subject to annual check-ups during which, where possible, they will be asked to sign an informed consent. These patients are subjected during the visits of normal clinical follow-up to:
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| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits in IBD patients | Quantification of gluten intake by IBD patients compared with the control population. Evaluation of foods excluded from the diet of IBD patients. | April 2021- April 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of weight | Assessment of weight (kilograms) in IBD patients | April 2021- April 2023 |
| Assessment of height | Assessment of height (meters) in IBD patients |
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Inclusion Criteria:
Exclusion Criteria:
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30 patients with IBD (15 CD and 15 RCU) and 15 patients from the control population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurizio Vecchi, doctor | Contact | 0255033418 | maurizio.vecchi@policlinico.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Elli, PhD | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | Recruiting | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32558265 | Result | 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. | |
| 27245762 | Result | 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. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D011350 | Proctocolitis |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| April 2021- April 2023 |
| Assessment of clinical disease activity | Evaluation of validated clinical activity indices for RCU in IBD patients (Mayo Score) | April 2021- April 2023 |
| Assessment of clinical disease activity | Evaluation of validated clinical activity indices for CD in IBD patients (Harvey-Bradshaw Index) | April 2021- April 2023 |
| 3317057 | Result | 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. |
| 22271464 | Result | 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. |
| 6102236 | Result | 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. |
| 32172690 | Result | 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. |
| D003092 | Colitis |
| D011349 | Proctitis |
| D003108 | Colonic Diseases |
| D012810 | Sigmoid Diseases |
| D012002 | Rectal Diseases |