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

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT05079932
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-09-23
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2023-04-01
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dietary habits in IBD patients	April 2021- April 2023	Quantification of gluten intake by IBD patients compared with the control population.; Evaluation of foods excluded from the diet of IBD patients.

Secondary Outcome Measures

Name	Time	Method
Assessment of height	April 2021- April 2023	Assessment of height (meters) in IBD patients
Assessment of weight	April 2021- April 2023	Assessment of weight (kilograms) in IBD patients
Assessment of clinical disease activity	April 2021- April 2023	Evaluation of validated clinical activity indices for CD in IBD patients (Harvey-Bradshaw Index)

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano; 🇮🇹 Milan, Italy