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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Irritable Bowel Syndrome; Gut Microbiome

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Martine Saint-Cyr, MD; Phone Number: 303-724-3242; Email: martine.saint-cyr@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with established IBD diagnosis (both well-controlled and active disease) for > 6 months

Description

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet-derived potential biomarkers	Serum, urine, and stool concentrations of TMAO, TMA, choline and carnitine	Collected within 4 weeks of consent
Dietary Intake - 24 Hour Food Recall	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.	Collected within 4 weeks of consent
Dietary Intake - BLOCK Questionnaire for Ages 8-17 - 2004 FFQ	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.	Collected within 4 weeks of consent
Fecal microbiome	Deep shotgun sequencing to assess the gut microbiome	Collected within 4 weeks of consent
Inflammatory markers	Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin	Collected within 4 weeks of consent

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammation; Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Other Study ID Numbers: 20-0369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No