Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD) - Main Study

• Conditions: Gut Microbiome; Inflammation; Irritable Bowel Syndrome

• Registration Number: NCT05014243
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2021-05-21
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20
• Study Start: 2023-08-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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