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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative rectocolitis, IBD, Crohn Disease, Gluten-free diet, Nutrition