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

NCT ID: NCT05014243

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

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.

Conditions

Gut Microbiome; Inflammation; Irritable Bowel Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Martine Saint-Cyr, MD

Role: CONTACT

martine.saint-cyr@cuanschutz.edu

303-724-3242

Other Identifiers

20-0369

Identifier Type: -

Identifier Source: org_study_id