NCT03855956已完成不适用
A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Kaleido Biosciences8 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
研究概览
简要总结
This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent
- •Be male or female, 18 to 70 years of age (inclusive)
- •Have a body mass index (BMI) ≥ 20.0 and < 40.0 kg/m2
- •Well-compensated cirrhosis
- •Negative for hepatocellular carcinoma (HCC)
- •Adequate safety laboratory values at Screening.
- •Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine
- •If of child bearing potential must follow contraceptive requirements of the protocol
- •Have reliable internet access
排除标准
- •Have evidence of decompensated liver disease.
- •History or active GI disease.
- •Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
- •Subject has a history of drug and/or alcohol abuse.
结局指标
主要结局
Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.
时间窗: Day -3 to Day 28.
Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.
次要结局
- Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 27.)
- . Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Change in ammonia in blood for KB174 compared to Maltodextrin.(Day -3 to Day 43.)
- Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Incidence of treatment-emergent adverse events from baseline to end of study.(Day -7 through Day 43 visit.)
- Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.(Day -3 to Day 29.)
- Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.(Day -7 through Day 43.)
- Incidence of serious adverse events from base baseline to end of study.(Day -7 through Day 43.)
- Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires(Day -7 through Day 43.)
研究者
研究点 (8)
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