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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Resistant Starch

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.

Group Type ACTIVE_COMPARATOR

Resistant Starch

Intervention Type OTHER

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

Placebo

Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo oral consumption of food-grade cornstarch

Interventions

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Resistant Starch

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

Intervention Type OTHER

Placebo

Placebo oral consumption of food-grade cornstarch

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No