NCT04508413已完成不适用
An Exploratory, 14-week, Open-label Clinical Food Study to Evaluate the Effects of KB295 in Adult Patients With Ulcerative Colitis (UC) Presenting With Mild-to-moderate UC Symptoms
Kaleido Biosciences5 个研究点 分布在 2 个国家目标入组 12 人开始时间: 2020年8月12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
- 12
- 试验地点
- 5
- 主要终点
- Number of patients experiencing any treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female, ≥18 and ≤75 years of age
- •Confirmed diagnosis of UC (>6 months) by endoscopy
- •Mild-to-moderate UC with at least 4 weeks of UC symptomatology prior to screening
- •Stable medication regimen for at least 2 weeks prior to screening, if on medication for UC
排除标准
- •Possible or confirmed diagnosis of Crohn's disease or indeterminate disease
- •History of isolated distal proctitis
- •Use of any antidiarrheal medications within the last 1 week prior to screening
- •Antibiotic treatment within the past 28 days prior to screening
- •Any non-UC related immunosuppressive medications other than purine analogs. Systemic corticosteroids including prednisone > 10 mg per day are excluded.
- •Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study
- •Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results
- •Treatment with any other investigational drugs within 28 days prior to the screening visit
结局指标
主要结局
Number of patients experiencing any treatment-emergent adverse events (TEAEs)
时间窗: Day -1 to Day 84
Number of patients experiencing discontinuations due to adverse events (AEs)
时间窗: Day -1 to Day 84
次要结局
未报告次要终点
研究者
研究点 (5)
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