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

Children's Hospital of Eastern Ontario

Status: Active, not recruiting

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Resistant Starch; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06301477

23/109X

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Resistant Starch

Active Comparator group

Description:

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.

Treatment:

Other: Resistant Starch

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo