A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.
研究概览
简要总结
The purpose of the study is 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 trial (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.
- •New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy.
- •Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points).
- •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.
- •Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess).
- •Requirement of oral antibiotics for other conditions (e.g. acne).
- •Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment.
- •Requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy.
- •Patients diagnosed with Inflammatory Bowel Disease-Unclassified.
- •Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.
研究组 & 干预措施
Resistant Starch
Once daily oral consumption of 7.5 g/m2 of an individually optimized resistant starch for approximately 5 months
干预措施: Resistant Starch (Other)
Placebo
Once daily oral consumption of a food-grade cornstarch that is readily digestible for approximately 5 months
干预措施: Placebo (Other)
结局指标
主要结局
Increased potential for butyrate production and its level at the mucosal luminal interface following ingestion of an individualized resistant starch as assessed by meta-omics analysis.
时间窗: 5 ± 1 months
Sustained increased potential of butyrate production 6 months following cessation of the use of individualized resistant starch as assessed by meta-omics analysis of stools.
时间窗: 12 ± 2 months
Compliance of resistant starch intake by product reconciliation.
时间窗: 5 ± 1 months
The percentage of eligible inflammatory bowel disease (IBD) patients who will enter a resistant starch-based ingestion trial.
时间窗: Enrollment
Threshold of interest will be 50%.
Compliance of resistant starch intake by patient report.
时间窗: 5 ± 1 months
次要结局
- Changes in patient, parent/caregiver reported quality of life outcomes as measured by the IMPACT III Questionnaires.(Enrollment, 5 ± 1 months, and 12 ± 2 months)
- Change in microbiome composition of cases towards the microbiome of controls as assessed by meta-omics analysis.(5 ± 1 months and 12 ± 2 months)
- Change in histological scoring of acute and chronic inflammation collected through biopsies during colonoscopies and assessed using Naini and Cortina score for Crohn's disease and the Robarts Histopathological Index (RHI) for Ulcerative Colitis.(Enrollment, and 5 ± 1 months)
- Changes in mitochondrial function due to ingestion of resistant starch as assessed by host proteomics of biopsy sampling.(Enrollment, and 5 ± 1 months)
- Change in clinical disease activity as measured by the wPCDAI for Crohn's Disease, the PUCAI and Partial Mayo Score for Ulcerative Colitis, and the PGA for both Crohn's Disease and Ulcerative Colitis.(Enrollment, 5 ± 1 months, and 12 ± 2 months)
- Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples.(Enrollment, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months)
- Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire.(Enrollment, 5 ± 1 months, and 12 ± 2 months)
- Change in endoscopic disease activity measured during colonoscopies using the SES-CD for Crohn's Disease and the Mayo Endoscopic Sub Score and UCEIS for Ulcerative Colitis.(Enrollment, and 5 ± 1 months)
研究者
David Mack
Director, CHEO IBD Centre
Children's Hospital of Eastern Ontario