PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis
研究概览
简要总结
To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.
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
The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8.0 to 16.9 years of age.
- •Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
- •Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon.
- •CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5).
- •Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD.
- •No changes in medical treatment for the previous month and without anticipated changes for the next month.
- •Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study.
排除标准
- •Allergy to RS or excipients.
- •Co-existing diagnosis with diabetes mellitus type
- •Treatment with another investigational drug or intervention throughout the study.
- •Current illicit drug or alcohol dependence.
- •Inability or unwillingness of an individual or legal guardian to give written informed consent.
- •Other conditions requiring immunomodulating or biological medications.
- •Pregnancy.
- •Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.
研究组 & 干预措施
Resistant Starch
Once daily oral consumption of either 7.5g/m2 or 5.0g/m2 (body surface area) of a resistant starch for 48 weeks that is individually optimized at 24 weeks.
干预措施: Resistant Starch (Other)
Placebo
Once daily oral consumption of a readily digestible food-grade cornstarch that resembles the study product in appearance, smell and taste for 48 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis
时间窗: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate.
Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis
时间窗: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production
Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis
时间窗: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers
次要结局
- Change in disease activity(Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Change in intensification as measured by anti-TNFa dose escalation(Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire(Baseline, 24 weeks, 48 weeks)
- Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples(Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P(Baseline, 24 weeks, 48 weeks)
- Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples(Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Change in intensification as measured by anti-TNFa interval shortening(Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire(Baseline, 24 weeks, 48 weeks)
研究者
David Mack
Director, CHEO IBD Centre
Children's Hospital of Eastern Ontario