OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

NCT04522271

Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

ACTIVE_NOT_RECRUITING NA

Safety and Maintenance Study of Entocort for Children With Crohn's Disease

NCT01453946

Crohn's Disease

COMPLETED PHASE3

Safety Study of Entocort for Children With Crohn's Disease

NCT01444092

Crohn's Disease

COMPLETED PHASE3

Trial of Mesalamine for the Treatment of Active Microscopic Colitis

NCT00952952

Microscopic Colitis Diarrhea

COMPLETED PHASE2/PHASE3

Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease

NCT02201693

Crohn's Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trail (OARS trial). Only Dr. Mack (Co-PI) can request to break the blind for safety reasons or eligibility for the OARS Trial; only Dr. Stintzi (Co-PI) will request to break the blind for interim analysis. Once the blind is broken, the patient will be discontinued from study product.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistant Starch

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

Group Type ACTIVE_COMPARATOR

Resistant Starch

Intervention Type OTHER

7.5 g resistant starch/m2 oral consumption

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo oral consumption of food-grade cornstarch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistant Starch

7.5 g resistant starch/m2 oral consumption

Intervention Type OTHER

Placebo

Placebo oral consumption of food-grade cornstarch

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No