Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 267
- 试验地点
- 8
- 主要终点
- Personalised nutrition Algorithm based on microbiome.
研究概览
简要总结
This is a three-arm, non-interventional observational study designed to investigate the relationship between Crohn's disease (CD), the microbiome, and diet in children.
详细描述
This is an international, multi-center observational study conducted at eight sites worldwide: Israel, Italy, Croatia, Spain, Sweden, the Netherlands, and Canada.
The study is designed to recruit a large cohort of children with newly diagnosed Crohn's disease (CD), as well as two control groups: healthy controls undergoing colonoscopy for non-specific abdominal pain and non-invasively characterized healthy controls. Participants are recruited across the participating sites and followed for a period of one year.
During clinical visits, blood samples will be collected, anthropometric measurements will be obtained, and participants will be assessed by the study physician. Brushings and biopsies will be collected during endoscopic examinations performed solely for clinical indications and not as part of the study procedures.
During the one-year follow-up period, participants will be asked to collect stool samples at home for assessment of microbiome composition and perform home fecal calprotectin tests. Participants will also be asked to continuously record their daily activities and dietary intake using a smartphone application.
The study aims to leverage the large-scale dataset collected to determine how individualized factors, particular in order to devise a personalized dietary interventions for pediatric patients with Crohn's disease.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CD study group - 'Consent form - Part 1'
- •Children with clinical suspicion for CD.
- •Between 6 and 18 years of age.
- •Naïve to any medical or nutritional intervention.
- •CD study group - 'Consent form - Part 2'
- •Children with CD confirmed by endoscopy (and based on accepted criteria)
- •Between 6 and 18 years of age.
- •Naïve to any medical or nutritional intervention.
- •Control group undergoing endoscopy children between 6 and 18 years of age undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions.
- •Control group not undergoing colonoscopy
- •Children with no symptoms or signs of gastrointestinal disease and no known medical conditions.
- •Children between 6 and 18 years of age. These children will be recruited from general pediatric clinics (children attending for routine check-up), orthopedic clinics, ophthalmology clinics or schools.
排除标准
- •CD study group
- •Any known autoimmune or rheumatologic disease.
- •Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- •Past or present history of malignancy.
- •Primary immunodeficiency.
- •Pregnancy in the last 6 months, breastfeeding.
- •Morbid obesity (BMI > 95th percentile for their age and gender).
- •Following particular dietary regimen/dietitian consultation/participation in another study.
- •Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- •Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- •Gut-related surgery, including bariatric surgery.
- •Inability of the participant and nuclear family to follow and utilize the smartphone application.
- •Control group undergoing endoscopy:
- •Any known autoimmune or rheumatologic disease.
- •Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- •Past or present history of malignancy.
- •Primary immunodeficiency.
- •Pregnancy in the last 6 months, breastfeeding.
- •Morbid obesity (BMI > 95th percentile for their age and gender).
- •Following particular dietary regimen/dietitian consultation/participation in another study.
- •Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- •Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- •Gut-related surgery, including bariatric surgery.
- •Control group not undergoing colonoscopy:
- •Any known autoimmune or rheumatologic disease.
- •Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- •Past or present history of malignancy.
- •Primary immunodeficiency.
- •Pregnancy in the last 6 months, breastfeeding.
- •Morbid obesity (BMI > 95th percentile for their age and gender).
- •Following particular dietary regimen/dietitian consultation/participation in another study.
- •Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- •Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- •Gut-related surgery, including bariatric surgery.
研究组 & 干预措施
Group A
Newly onset Crohn's disease patients
干预措施: endoscopy examination (Other)
Group B
Children undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions.
干预措施: endoscopy examination (Other)
Group C
Healthy individuals - not undergoing endoscopy
结局指标
主要结局
Personalised nutrition Algorithm based on microbiome.
时间窗: 3 years
Using a machine learning algorithm we will create a trained personalized predictor enabling to devise tailor-made dietary regimens to induce remission in pediatric CD using big data, which will be accumulated over a period of one year since disease onset. Personalized features will include: microbiome ( metagenomic sequencing of stool microbiome), blood tests, nutritional questionnaires and dietary logs, and disease states (via fecal calprotectin test) in children with Crohn's disease.
次要结局
未报告次要终点
研究者
Eran Elinav
Principal Investigator, Host-Microbiome Interaction Research Group
Weizmann Institute of Science