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PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

NCT06301477 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Crohn Disease

Interventions

OTHER

Resistant Starch

7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption

OTHER

Placebo

Placebo oral consumption of food-grade cornstarch

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-08
Completion
2027-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301477 on ClinicalTrials.gov