Pilot Study for the Evaluation of Food Choices in Patients With Inflammatory Bowel Diseases (MICI2021)

Inflammatory Bowel Diseases Clinical Trial

— MICI2021  

Official title:

Pilot Study for the Evaluation of Food Choices and Exclusion of Gluten From the Diet in Patients With Inflammatory Bowel Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079932
• Other study ID #: 612_2021
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

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