Crohn DiseaseNCT04522271
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
A study testing Resistant Starch in people with Crohn Disease and Ulcerative Colitis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- 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
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2020to 31 Dec 2026
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
- Enrolled in the main parent study.
- New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy.
- Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points).
- Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
- Willing to provide consent/assent for the collection of stool samples.
Who cannot join
- Allergy to resistant starch or excipients.
- Co-existing diagnosis with diabetes mellitus.
- Treatment with another investigational drug or intervention throughout the study.
- Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of an individual or legal guardian to give written informed consent.
- Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess).
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- Requirement of oral antibiotics for other conditions (e.g. acne).
- Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment.
- Requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy.
- Patients diagnosed with Inflammatory Bowel Disease-Unclassified.
- Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.
- Being tested
- Resistant Starch, Placebo
- Keywords
- Resistant Starch, Microbiome
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchOther
7.5 g resistant starch/m2 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 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months Receives: Other: Resistant Starch |
| Placebo | Placebo comparator | Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.
Measured: 5 ± 1 months
Sustained increased potential of butyrate production 6 months following cessation of the use of individualized resistant starch as assessed by meta-omics analysis of stools.
Measured: 12 ± 2 months
The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.
Threshold of interest will be 50%.
Measured: Enrollment
Compliance of resistant starch intake by patient report.
Measured: 5 ± 1 months
Compliance of resistant starch intake by product reconciliation.
Measured: 5 ± 1 months
Secondary outcomes (8)
Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.
Measured: 5 ± 1 months and 12 ± 2 months
Changes in mitochondrial function due to ingestion of resistant starch as assessed by host proteomics of biopsy sampling.
Measured: Enrollment, and 5 ± 1 months
Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis.
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). The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (<10 = remission, 10 to 34 = mild, 35 to 64= moderate, >65 = severe). Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe). The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).
Measured: Enrollment, 5 ± 1 months, and 12 ± 2 months
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: Enrollment, 5 ± 1 months, and 12 ± 2 months
Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.
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. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life.
Measured: Enrollment, 5 ± 1 months, and 12 ± 2 months
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.
Measured: Enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months
Change in endoscopic disease activity measured during colonoscopies using the SES-CD for Crohn's Disease and the Mayo Endoscopic Sub Score and UCEIS for Ulcerative Colitis.
The Simple Endoscopic Score for Crohn's Disease (SES-CD) measures disease inflammation (0 to 2= inactive, 3 to 6 = mild, 7 to 15 = moderate, >16 = severe). Mayo Endoscopic Sub Scores range from 0 to 3, with 0 representing a normal mucosa or inactive disease and 3 representing severe activity (spontaneous bleeding and large ulcerations). The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ranges from 0 to 8 (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, and 7 to 8 = severe).
Measured: Enrollment, and 5 ± 1 months
Change in histological scoring of acute and chronic inflammation collected through biopsies during colonoscopies and assessed using Naini and Cortina score for Crohn's disease and the Robarts Histopathological Index (RHI) for Ulcerative Colitis.
The Naini and Cortina score ranges from 0 to 10 for ileitis and 0 to 17 for colitis. For ileitis, the histopathological support for having IBD is either low (score < 2), moderate (score is 3 to 4), or high (score ≥ 5). For colitis, the likelihood of having IBD is either low (≤3), moderate (score is 4 to 8), or high (score ≥ 9). The Robarts Histopathological Index score ranges from 0 to 33 with a higher score representing more severe inflammation.
Measured: Enrollment, and 5 ± 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start25 Aug 2020
- Primary completion25 May 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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, parallel, pilot clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- Investigators
- David Mack, MD, FRCPC, Principal investigator, Children's Hospital of Eastern OntarioAlain Stintzi, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522271
- Sponsor's protocol ID
- 20/04E
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2020
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olson JL, Castillo G, Palumbo A, Harrison M, Singleton R, Lalu MM, Fergusson DA, Stintzi A, Mack DR, Presseau J. A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric Inflammatory Bowel Disease. PLoS One. 2024 Jul 30;19(7):e0292709. doi: 10.1371/journal.pone.0292709. eCollection 2024.
PubMed 39078826
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
- A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT04522271
- Acronym / sponsor ID
- 20/04E
- Keywords
- Resistant Starch, Microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2020 (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 purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.
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, parallel, pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch | Active comparator | Other: Resistant StarchOnce daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months |
| Placebo | Placebo comparator | Other: PlaceboOnce daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
- Enrolled in the main parent study.
- New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy.
- Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points).
- Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
Key exclusion criteria (11 listed)
- Allergy to resistant starch or excipients.
- Co-existing diagnosis with diabetes mellitus.
- Treatment with another investigational drug or intervention throughout the study.
- Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- 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 Starch7.5 g resistant starch/m2 oral consumption | Other | Resistant Starch |
| PlaceboPlacebo oral consumption of food-grade cornstarch | Other | Placebo |
Primary outcome
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.
Time frame: 5 ± 1 months
Sustained increased potential of butyrate production 6 months following cessation of the use of individualized resistant starch as assessed by meta-omics analysis of stools.
Time frame: 12 ± 2 months
The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.
Time frame: Enrollment
Threshold of interest will be 50%.
Compliance of resistant starch intake by patient report.
Time frame: 5 ± 1 months
Compliance of resistant starch intake by product reconciliation.
Time frame: 5 ± 1 months
8 secondary outcomes
Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.
Time frame: 5 ± 1 months and 12 ± 2 months
Changes in mitochondrial function due to ingestion of resistant starch as assessed by host proteomics of biopsy sampling.
Time frame: Enrollment, and 5 ± 1 months
Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis.
Time frame: Enrollment, 5 ± 1 months, and 12 ± 2 months
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.
Time frame: Enrollment, 5 ± 1 months, and 12 ± 2 months
Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.
Time frame: Enrollment, 5 ± 1 months, and 12 ± 2 months
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.
Time frame: Enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months
Change in endoscopic disease activity measured during colonoscopies using the SES-CD for Crohn's Disease and the Mayo Endoscopic Sub Score and UCEIS for Ulcerative Colitis.
Time frame: Enrollment, and 5 ± 1 months
Change in histological scoring of acute and chronic inflammation collected through biopsies during colonoscopies and assessed using Naini and Cortina score for Crohn's disease and the Robarts Histopathological Index (RHI) for Ulcerative Colitis.
Time frame: Enrollment, and 5 ± 1 months
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.
- Derived from this study: PubMed 39078826Olson JL, Castillo G, Palumbo A, Harrison M, Singleton R, Lalu MM, Fergusson DA, Stintzi A, Mack DR, Presseau J. A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric Inflammatory Bowel Disease. PLoS One. 2024 Jul 30;19(7):e0292709. doi: 10.1371/journal.pone.0292709. eCollection 2024.
- 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.
David Mack, MD, FRCPC principal investigator
Children's Hospital of Eastern Ontario
Alain Stintzi, PhD principal investigator
University of Ottawa
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 Crohn Disease and Ulcerative Colitis, 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 6 inclusion and 11 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?
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis. (time frame: 5 ± 1 months). 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?
On the ClinicalTrials.gov record for NCT04522271, which also lists 1 linked publication.
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.