OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Resistant Starch
Once daily oral consumption of 7.5g/m2 of an individually optimized resistant starch for approximately 6 months
干预措施: Resistant Starch (Other)
Placebo
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 6 months
干预措施: Placebo (Other)
结局指标
主要结局
Sustained potential for butyrate production following 6 months use of individualized resistant starch post randomization as assessed by meta-omics analysis.
时间窗: 12 ± 2 months
Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.
时间窗: 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.
时间窗: 6 ± 1 months
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
研究者
David Mack
Director, CHEO IBD Centre
Children's Hospital of Eastern Ontario