A Multi-center Study to Characterize the Gut Microbiome of Individuals With End-stage Renal Disease Treated With Maintenance Hemodialysis, and to Explore Effects of P-inulin on the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Within Participant Variability in Microbiome Composition by Treatment Phase
研究概览
简要总结
The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.
详细描述
This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. The study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. Secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis therapy for end-stage renal disease
- •At least 18 years of age
- •At least 90 days since hemodialysis initiation
- •Self-reported average stool frequency of at least 1 every other day
- •For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of p-inulin.
- •Ability to provide consent
排除标准
- •Use of prebiotics or probiotics during the past 8 weeks
- •Consumption of probiotic yogurt during the past 2 weeks
- •Use of antibiotics within the past 8 weeks
- •Presence of HIV infection, chronic wound infection, osteomyelitis, or current hemodialysis
- •Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
- •Cirrhosis or chronic active hepatitis
- •Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
- •Expected survival less than 9 months
- •Pregnancy, anticipated pregnancy, or breastfeeding
- •Incarceration
- •Participation in another intervention study
- •Severe anemia defined as hemoglobin <9.0 g/dl within the past 4 weeks as documented in the dialysis unit patient record
结局指标
主要结局
Within Participant Variability in Microbiome Composition by Treatment Phase
时间窗: 28 weeks
The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition.
Within Participant Variability in Plasma Metabolome by Treatment Phase
时间窗: 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment)
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.
Within Participant Variability in Stool Metabolome by Treatment Phase
时间窗: 28 weeks
The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms.
次要结局
- Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome)(12 weeks)
- Rate of Enrollment Refusal (Feasibility Outcome)(1 year)
- Adherence Rate of P-inulin Use (Feasibility Outcome)(12 weeks)
- Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome)(GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28.)
- Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome)(12 weeks)
- Number of Participants With Adverse Events (Safety Outcome)(28 weeks)
- Number of Serious Adverse Events (Safety Outcome)(28 weeks)
- Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)(28 weeks)
- Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome)(28 weeks)
- Rate of Study Withdrawal (Feasibility Outcome)(28 weeks)