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NCT04520594
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
NA trial testing Resistant Starch in Crohn Disease in 100 participants. Participants enrolled and being followed up; not accepting new ones.
5 November 2024
Quick facts
| Lead sponsor | Children's Hospital of Eastern Ontario |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 3 March 2021 |
| Primary completion | 5 November 2024 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Resistant Starch
- Placebo
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Children's Hospital of Eastern Ontario
Who can join
Adults 5 to 17, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to 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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel technologies to characterize and engineer the microbiome in inflammatory bowel disease.
Boix-Amorós A, Monaco H, Sambataro E, Clemente JC. · · 2022 · cited 10× · PMID 36104776 · DOI 10.1080/19490976.2022.2107866 -
Prebiotics for induction and maintenance of remission in ulcerative colitis.
Sinopoulou V, Gordon M, Gregory V, Saadeh A, et al · · 2024 · cited 7× · PMID 38501688 · DOI 10.1002/14651858.cd015084.pub2 -
A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric Inflammatory Bowel Disease.
Olson JL, Castillo G, Palumbo A, Harrison M, et al · · 2024 · PMID 39078826 · DOI 10.1371/journal.pone.0292709 -
RapidAIM 2.0: a high-throughput assay to study functional response of human gut microbiome to xenobiotics
Li L, Mayne J. · · 2024 -
A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric IBD
Olson JL, Castillo G, Palumbo A, Harrison M, et al · · 2023 · DOI 10.1101/2023.09.27.23296250
Verify or expand the search:
- PubMed search for NCT04520594
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Resistant Starch
Trials testing the same drug.
- NCT06301477 — PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial · NA · active not recruiting
- NCT04522271 — Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) · NA · active not recruiting
- NCT03356990 — Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease · NA · completed
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other Children's Hospital of Eastern Ontario trials
Trials by the same sponsor.
- NCT06801366 — VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children · recruiting
- NCT06816875 — Comparison of the User Experience of Four Nasal Aspirators in Infants · NA · completed
- NCT06301477 — PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial · NA · active not recruiting
- NCT06232733 — HELP (HEalthy Lifestyles Project) for Youth With Mental Distress · NA · recruiting
- NCT06065215 — Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04520594 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Eastern Ontario
- Last refreshed: 29 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04520594.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing