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.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Collecting questionnaires and biological samples.
- Кому может быть актуально
- Состояния в реестре: Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), Ulcerative Colitis (UC). Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Вмешательства
- Другое Collecting questionnaires and biological samples
For each family member will be collected a 3-days food diary, a food frequencies questionnaire and a questionnaire assessing the adherence to the mediterranean diet. Additionally, a blood sample for trascriptomic analysis and a fecal sample for gut microbiota analysis will be collected
Первичные конечные точки
- 3-days food diary, kidmed and medi-lite scores [Срок оценки: After two weeks]
Вторичные конечные точки (1)
- Percentage of families with microbiota alteration [Срок оценки: After 6 months]
Критерии участия
Критерии включения
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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Италия · 4 центра
- AOU Meyer IRCCS — Florence
- Università La Sapienza di Roma — Roma
- Università di Foggia — Foggia
- Ospedale Villa Sofia Cervello, Università di Palermo — Palermo
Идентификаторы
NCT: NCT06862843 · DIETA-MICIREUMA