Gut MicrobiomeTAMED IBDNCT05014243
Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD) - Main Study
An observational study of Gut Microbiome and Inflammation, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Gut Microbiome, Inflammation, Irritable Bowel Syndrome
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with established IBD diagnosis (both well-controlled and active disease) for > 6 months
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Inflammation, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet-derived potential biomarkers
Serum, urine, and stool concentrations of TMAO, TMA, choline and carnitine
Measured: 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.
Measured: 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.
Measured: Collected within 4 weeks of consent
Fecal microbiome
Deep shotgun sequencing to assess the gut microbiome
Measured: Collected within 4 weeks of consent
Inflammatory markers
Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin
Measured: Collected within 4 weeks of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014243
- Sponsor's protocol ID
- 20-0369
- Acronym
- TAMED IBD
- Status last verified
- Aug 2021
- First submitted
- 21 May 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT05014243
- Acronym / sponsor ID
- TAMED IBD / 20-0369
- Conditions
- Gut Microbiome, Inflammation, Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with established IBD diagnosis (both well-controlled and active disease) for > 6 months
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diet-derived potential biomarkers
Time frame: Collected within 4 weeks of consent
Serum, urine, and stool concentrations of TMAO, TMA, choline and carnitine
Dietary Intake - 24 Hour Food Recall
Time frame: 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
Time frame: 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
Time frame: Collected within 4 weeks of consent
Deep shotgun sequencing to assess the gut microbiome
Inflammatory markers
Time frame: Collected within 4 weeks of consent
Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and calprotectin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiome and Inflammation, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine Saint-Cyr, MD (303-724-3242, martine.saint-cyr@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet-derived potential biomarkers (time frame: Collected within 4 weeks of consent). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.