NCT06301477Active, not recruiting
PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 8 Dec 2025
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Diseases
- Crohn's disease
- NCT number
- NCT06301477
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 1 Dec 2024 to the primary completion date, 8 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with another investigational drug or intervention throughout the study.
- Current illicit drug or alcohol dependence.
Other illness
- Allergy to RS or excipients.
- Co-existing diagnosis with diabetes mellitus type 1.
- Other conditions requiring immunomodulating or biological medications.
Other
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
- Pregnancy.
- Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.
Who the study is looking for
- Age between 8.0 to 16.9 years of age.
- Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
- Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon.
- CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5).
- Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD.
- No changes in medical treatment for the previous month and without anticipated changes for the next month.
- Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study.
Age in the registry: 8 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.