OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

Children's Hospital of Eastern Ontario

Status: Active, not recruiting

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Resistant Starch; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04520594

20/16E

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
• Enrolled in the main parent study.
• Existing Crohn's disease or ulcerative colitis diagnosis.
• In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month.
• Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
• Willing to provide consent/assent for the collection of stool samples.

Exclusion criteria

• Allergy to resistant starch or excipients.
• Co-existing diagnosis with diabetes mellitus.
• Treatment with another investigational drug or intervention throughout the study.
• Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of an individual or legal guardian to give written informed consent.
• Concomitant chronic disease requiring medications.
• Requirement for antibiotic therapy >2 weeks duration.
• Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.
• Patients with previous intestinal surgery.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

Resistant Starch

Active Comparator group

Description:

Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months

Treatment:

Other: Resistant Starch

Placebo

Placebo Comparator group

Description:

Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months

Treatment:

Other: Placebo