Pilot Study for the Evaluation of Food Choices and Exclusion of Gluten From the Diet in Patients With Inflammatory Bowel Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Dietary habits in IBD patients
- Last Updated
- 4 years ago
Overview
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).
Investigators
Luca Elli, MD, PhD
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Dietary habits in IBD patients
Time Frame: 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 Outcomes
- Assessment of height(April 2021- April 2023)
- Assessment of weight(April 2021- April 2023)
- Assessment of clinical disease activity(April 2021- April 2023)