NCT04603378已完成不适用
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects Using a Stable Isotope
Kaleido Biosciences2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年9月18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
- 47
- 试验地点
- 2
- 主要终点
- Number of patients experiencing any treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This exploratory, randomized, double-blind, placebo-controlled study aims to explore the effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable isotope.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:
- •Willing to provide multiple stool samples
- •Be male or female, ≥18 and <50 years of age
- •Have a body mass index ≥18 and <50 kg/m2
- •No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection
- •Willing to adhere to dietary requirements as stated in the protocol
- •Willing to continue usual exercise routine
- •Willing to continue taking any current supplements and vitamins (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study
- •Patients will be excluded from the study if they meet any of the following criteria at screening :
- •Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid prebiotic or probiotic dietary supplements for the duration of the study
- •Currently taking, or have taken during the last seven days prior to enrollment, drugs or other compounds that modulate GI motility
- •Currently taking bismuth, or have taken bismuth within seven days prior to enrollment
- •Recent history (within six weeks of Screening Visit) of the following condition requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
- •Systemic antibiotics taken within the previous three months (prior to Screening Visit).
- •History of or active inflammatory bowel disease
- •History of or active irritable bowel syndrome
- •History of or active autoimmune disease.
- •History of or active GI malignancy.
- •Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test.
排除标准
- 未提供
结局指标
主要结局
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
时间窗: Day -8 to Day 29
次要结局
未报告次要终点
研究者
研究点 (2)
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