Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Diet-derived potential biomarkers
研究概览
简要总结
The overall goal of the study is to investigate the dietary differences between children with well-controlled inflammatory bowel disease (IBD) and those with active disease by using targeted food metabolomics. The utilization of the application of targeted metabolomics allows for the investigation of specific components of foods and their effects in IBD and inflammation, which may inform future dietary recommendations for IBD patients.
详细描述
The investigators overall hypothesis is that higher intake of animal origin foods lead to higher concentrations of TMAO and its precursors (TMA, choline and carnitine), which causes gut microbiota dysbiosis, ultimately resulting in elevated inflammatory markers (systemic and/or fecal) in pediatric inflammatory bowel disease (IBD).
The two primary aims include:
Aim 1: Examine the relationship between IBD activity, dietary patterns, and diet-derived potential biomarkers in serum and urine.
Aim 2: Investigate the association between IBD activity, dietary patterns, gut microbiome, and diet-derived potential biomarkers in stool.
Investigators will also explore the integrated relationship between disease activity, diet, gut microbiome, diet-derived potential biomarkers, and inflammatory markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •Established IBD diagnosis (both well-controlled and active disease) for > 6 months
- •Followed by the Children's Hospital Colorado (CHCO) IBD Center
- •Ages 8-18 years
排除标准
- •Vegan diet
- •Exclusive enteral nutrition (EEN) currently or within 2 weeks of enrollment
- •History of full colectomy
- •Ongoing active gastrointestinal infection
- •Severe malnutrition (BMI less than 5th percentile)
- •Presence of ostomy
- •Recent medication changes
结局指标
主要结局
Diet-derived potential biomarkers
时间窗: Collected within 4 weeks of consent
Serum, urine, and stool concentrations of TMAO, TMA, choline and carnitine
Dietary Intake - 24 Hour Food Recall
时间窗: Collected within 4 weeks of consent
The Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment is used to collect recall and food record data and measures healthy eating and overall diet quality. Macronutrient composition and mean intake will be reported.
Dietary Intake - BLOCK Questionnaire for Ages 8-17 - 2004 FFQ
时间窗: Collected within 4 weeks of consent
BLOCK includes 77 food items. Individual portion size is asked, and pictures are provided to enhance accuracy of quantification. BLOCK will be analyzed for each subject and raw data for nutrient intake. The number of servings of food groups will be assessed, and specific nutrient intake will be calculated and reported as mean intake.
Fecal microbiome
时间窗: Collected within 4 weeks of consent
Deep shotgun sequencing to assess the gut microbiome
Inflammatory markers
时间窗: Collected within 4 weeks of consent
Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin
次要结局
未报告次要终点