Inflammatory Bowel DiseasesPROMOTENCT06301477
PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
A study testing Resistant Starch in people with Inflammatory Bowel Diseases and Crohn Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- Resistant Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Allergy to RS or excipients.
- Co-existing diagnosis with diabetes mellitus type 1.
- Treatment with another investigational drug or intervention throughout the study.
- Current illicit drug or alcohol dependence.
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
- Other conditions requiring immunomodulating or biological medications.
- Pregnancy.
- Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Being tested
- Resistant Starch, Placebo
- Keywords
- Resistant Starch, Microbiome, anti-TNF
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchOther
7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption
PlaceboOther
Placebo oral consumption of food-grade cornstarch
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch | Active comparator | Once daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks. Receives: Other: Resistant Starch |
| Placebo | Placebo comparator | Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis
Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis
Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate.
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis
Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Secondary outcomes (8)
Change in intensification as measured by anti-TNFa dose escalation
To help contextualize the anti-TNFa dose escalation (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change in intensification as measured by anti-TNFa interval shortening
To help contextualize the anti-TNFa interval shortening (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change in disease activity
Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (<12.5 = remission, 12.5 to 40.0 = mild, >40.0 = moderate, >57.5 = severe).
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples
Measure of fecal calprotectin
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples
Measure of c-reactive protein
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire
The IBD Disability Index consists of 28 questions and a higher overall score is indicative of greater disability.
Measured: Baseline, 24 weeks, 48 weeks
Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire
The IMPACT III questionnaire ( a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life.
Measured: Baseline, 24 weeks, 48 weeks
Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P
The IMPACT III-P questionnaire ( a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life.
Measured: Baseline, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Dec 2024
- Primary completion8 Dec 2025
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, placebo-controlled, double-blinded, pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mack, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301477
- Sponsor's protocol ID
- 23/109X
- Acronym
- PROMOTE
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2024
- Last updated
- 29 Jan 2026
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
- ClinicalTrials.gov ID
- NCT06301477
- Acronym / sponsor ID
- PROMOTE / 23/109X
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- Resistant Starch, Microbiome, anti-TNF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Mar 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, randomized, placebo-controlled, double-blinded, pilot trial
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch | Active comparator | Other: Resistant StarchOnce daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks. |
| Placebo | Placebo comparator | Other: PlaceboOnce daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Allergy to RS or excipients.
- Co-existing diagnosis with diabetes mellitus type 1.
- Treatment with another investigational drug or intervention throughout the study.
- Current illicit drug or alcohol dependence.
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Starch7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption | Other | Resistant Starch |
| PlaceboPlacebo oral consumption of food-grade cornstarch | Other | Placebo |
Primary outcome
Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production
Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate.
Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers
8 secondary outcomes
Change in intensification as measured by anti-TNFa dose escalation
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change in intensification as measured by anti-TNFa interval shortening
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change in disease activity
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire
Time frame: Baseline, 24 weeks, 48 weeks
Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire
Time frame: Baseline, 24 weeks, 48 weeks
Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P
Time frame: Baseline, 24 weeks, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch in people with Inflammatory Bowel Diseases and Crohn Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis (time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.). The study lists 3 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 29 Jan 2026.