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

NCT06301477 | Active Not Recruiting

• 1 other identifier: 23/109X
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Resistant Starch; Microbiome; anti-TNF

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

Secondary Outcomes (8)

• Change in intensification as measured by anti-TNFa dose escalation

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Change in intensification as measured by anti-TNFa interval shortening

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Change in disease activity

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples

  Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Study Arms (2)

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.

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

Other: Placebo

Interventions

Resistant Starch OTHER

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

Resistant Starch

Placebo OTHER

Placebo oral consumption of food-grade cornstarch

Placebo

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CHEO IBD Centre

Model Details: A single-center, randomized, placebo-controlled, double-blinded, pilot trial

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 8, 2024
• Study Start: December 1, 2024
• Primary Completion: December 8, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)