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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05014243
Acronym
TAMED IBD
Enrollment
100
Registered
2021-08-20
Start date
2023-08-01
Completion date
2024-08-01
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiome, Inflammation, Irritable Bowel Syndrome

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.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diet-derived potential biomarkersCollected within 4 weeks of consentSerum, urine, and stool concentrations of TMAO, TMA, choline and carnitine
Dietary Intake - 24 Hour Food RecallCollected within 4 weeks of consentThe 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 FFQCollected within 4 weeks of consentBLOCK 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 microbiomeCollected within 4 weeks of consentDeep shotgun sequencing to assess the gut microbiome
Inflammatory markersCollected within 4 weeks of consentErythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin

Contacts

Primary ContactMartine Saint-Cyr, MD
martine.saint-cyr@cuanschutz.edu303-724-3242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026