OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial

Not Applicable

Active, not recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Other: Placebo; Other: Resistant Starch

• Registration Number: NCT04520594
• Lead Sponsor: Children's Hospital of Eastern Ontario

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2021-03-03
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months
Resistant Starch	Resistant Starch	Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months

Primary Outcome Measures

Name	Time	Method
Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.	12 ± 2 months
Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.	6 ± 1 months and 12 ± 2 months
Increased potential of butyrate production following the use of individualized resistant starch, as assessed by meta-omics analysis.	6 ± 1 months

Secondary Outcome Measures

Name	Time	Method
Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	The IBD disability index consists of 28 questions and a higher overall score is indicative of greater disability.
Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.	Enrollment, 3 ± 1 months, 6 ± 1 months, 9 ± 1 months, and 12 ± 2 months
Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (\<12.5 = remission, 12.5 to 40.0 = mild, \>40.0 = moderate, \>57.5 = severe).
Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	The IMPACT III questionnaire (a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life. The IMPACT III-P Questionnaire is to be completed by the caregiver/guardian with a higher score also representing a higher quality of life.
Change in clinical disease activity as measured by the PUCAI for Ulcerative Colitis.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	The Pediatric Ulcerative Colitis Activity Index (PUCAI) ranges from 0 to 85 points (\<10 = remission, 10 to 34 = mild, 35 to 64= moderate, \>65 = severe).
Change in clinical disease activity as measured by the PGA for both Crohn's Disease and Ulcerative Colitis.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	The Physician Global Assessment (PGA) ranges from 0 to 3 points (0 = normal, 1 = mild, 2 = moderate, 3 = severe).
Change in clinical disease activity as measured by the Partial Mayo Score for Ulcerative Colitis.	Enrollment, 3 ± 1 months, 6 ± 1 months , 9 ± 1 months and 12 ± 2 months	The Partial Mayo Score ranges from 0 to 9 points (0 to 1 = remission, 2 to 4 = mild, 5 to 6 = moderate, 7 to 9 = severe).

Trial Locations

Locations (1)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada