Pilot Study for the Evaluation of Food Choices and Exclusion of Gluten From the Diet in Patients With Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Dietary habits in IBD patients
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Dietary habits in IBD patients
时间窗: 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.
次要结局
- Assessment of height(April 2021- April 2023)
- Assessment of weight(April 2021- April 2023)
- Assessment of clinical disease activity(April 2021- April 2023)
研究者
Luca Elli, MD, PhD
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico