NCT03944369终止不适用
A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointesinal Tracts Are Colonized With Multiple Drug-resistant Organisms
Kaleido Biosciences16 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 16
- 主要终点
- Incidence of product-related treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female, ≥18 years of age
- •Positive stool culture for at least one of these three organisms: VRE, ESBLE or CRE
- •Be willing and able to give informed consent
- •If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in phase and willing to remain consistent throughout the study
- •If subject is female: subject is surgically sterile or post-menopausal (12 months with no menses without an alternate medical cause); or if subject is a female of childbearing potential, must have a negative urine pregnancy test at Screening, must not be lactating, and must agree to abstain from sexual activity or agree to use one highly effective method of contraception for the duration of the study
排除标准
- •Planned escalation of immunosuppression
- •Neutropenia (≤500 absolute neutrophil count per μL)
- •Allogenic stem cell transplant recipients with ongoing gastrointestinal disease
- •Rapidly progressive or terminal illness
- •Hemodynamic instability, or any other significant systemic, unstable or untreated disease
- •Currently receiving or anticipated to require systemic (oral or IV anti-infective) or gut-directed antibacterial therapy
- •Recent history of the following conditions requiring medical attention: known or suspected gastrointestinal (GI) infection (e.g., viral or bacterial gastroenteritis) or inflammatory bowel disease
- •Major intra-abdominal surgery related to the bowel within the 3 months prior to Run-In
- •Receiving total parenteral nutrition
- •Contraindications, sensitivity, or known allergy to the use of the study product or its components
- •Individuals who, in the opinion of the Investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures (e.g., planned procedures)
结局指标
主要结局
Incidence of product-related treatment-emergent adverse events (TEAEs)
时间窗: Day -7 through Day 42
Incidence of serious adverse events (SAEs)
时间窗: Day -7 through Day 42
Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires.
时间窗: Day -7 through Day 42]
Evaluate the effect of KB109 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid)
次要结局
- 1. Proportion of subjects with a reduction from baseline on Day 28 in the relative abundance of taxa of interest (Enterobacteriaceae, Enterococcus, and C. difficile, individually) as measured by metagenomic sequencing.(Day -1 to Day 28)
研究者
研究点 (16)
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