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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	8 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05014243
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gut Microbiome, Inflammation, Irritable Bowel Syndrome

Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Martine Saint-Cyr, MD

martine.saint-cyr@cuanschutz.edu

303-724-3242

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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