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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05079932
Other study ID # 612_2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date May 31, 2024

Study information

Verified date October 2021
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Maurizio Vecchi, doctor
Phone 0255033418
Email maurizio.vecchi@policlinico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

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: - 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date May 31, 2024
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: 18 years - 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: - Pregnancy status - 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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Elli L, Bascuñán 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 stu — View Citation

Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Assessment of weight Assessment of weight (kilograms) in IBD patients April 2021- April 2023
Secondary Assessment of height Assessment of height (meters) in IBD patients April 2021- April 2023
Secondary Assessment of clinical disease activity Evaluation of validated clinical activity indices for RCU in IBD patients (Mayo Score) April 2021- April 2023
Secondary Assessment of clinical disease activity Evaluation of validated clinical activity indices for CD in IBD patients (Harvey-Bradshaw Index) April 2021- April 2023
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