TAMED IBD: Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD) - Main Study
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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.
Investigators will recruit 100 subjects with known IBD of > 6 months duration. Subjects will be asked to complete dietary questionnaires, and provide stool, urine, and blood samples.
Study Design
Outcome Measures
Primary Outcome Measures
- Diet-derived potential biomarkers [Collected within 4 weeks of consent]
Serum, urine, and stool concentrations of TMAO, TMA, choline and carnitine
- Dietary Intake - 24 Hour Food Recall [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 [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 [Collected within 4 weeks of consent]
Deep shotgun sequencing to assess the gut microbiome
- Inflammatory markers [Collected within 4 weeks of consent]
Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and Female
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Established IBD diagnosis (both well-controlled and active disease) for > 6 months
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Followed by the Children's Hospital Colorado (CHCO) IBD Center
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Ages 8-18 years
Exclusion Criteria:
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Vegan diet
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Exclusive enteral nutrition (EEN) currently or within 2 weeks of enrollment
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History of full colectomy
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Ongoing active gastrointestinal infection
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Severe malnutrition (BMI less than 5th percentile)
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Presence of ostomy
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Recent medication changes
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Colorado, Denver
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-0369