Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- 3-days food diary, kidmed and medi-lite scores
研究概览
简要总结
The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named TRANSMIC, approved by the pediatric ethics committee of the Tuscany region. TRANSMIC was an integral part of a European research project within the joint programming initiative (JPI), under the HDHL-INTIMIC theme: "A Healthy Diet for a Healthy Life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health.
Understanding the role of diet in inflammatory bowel diseases (IBD) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as JIA, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For families with at least one child/adult affected by IBD/JIA:
- •Father and mother with children aged between 0-18 years, in good health.
- •At least one adult or one child affected by IBD, or a child affected by JIA, regardless of ongoing therapy and without distinction of disease severity or activity.
- •For healthy families:
- •Father and mother with children aged between 0-18 years, in good health and not affected by chronic inflammatory bowel diseases or chronic autoimmune inflammatory diseases in general.
排除标准
- •For subjects affected by IBD:
- •Monogenic disease
- •Children with an ileostomy or who have undergone a colectomy
- •For subjects affected by JIA:
- •No exclusion criteria
- •For healthy subjects:
- •Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.
结局指标
主要结局
3-days food diary, kidmed and medi-lite scores
时间窗: After two weeks
次要结局
- Percentage of families with microbiota alteration(After 6 months)
研究者
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS