Phase 1 Open Label Trial of Nissle 1917 to Assess Safety and Tolerance in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events associated with ingestion of E. coli Nissle 1917
研究概览
简要总结
Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat gastrointestinal disorders and infections. The investigators will assess the safety and tolerability of this medication in Americans in a Phase 1 trial.
详细描述
Background: Nissle 1917 is an E. coli based probiotic that has been successfully used in Europe for close to 100 years to treat largely gastrointestinal disorders like inflammatory bowel disease, gastroenteritis, and irritable bowel syndrome. In addition to those disorders, we believe that Nissle 1917 is a promising alternative therapy for prevention of urinary tract infections in susceptible individuals.
Purpose: The Phase 1 trial will use Nissle 1917 in healthy adult patient volunteers for the first time in the United States. The investigators will track the frequency and incidence of side effects and adverse events.
Participants:
20 adult (>21 years of age) healthy volunteers
Protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteer of age 21 years or older
排除标准
- •Any individual with an active urinary tract infection (UTI)
- •Any individual with an acute illness within the past 7 days
- •Any individual with neurogenic bladder or with vesicoureteral reflux
- •Any individual with any anatomic abnormality, congenital or acquired, of the urinary tract system
- •Any individual with any anatomic abnormality, congenital or acquired, of the gastrointestinal tract
- •Any individual with untreated dysfunctional elimination syndrome
- •Immunocompromised patients
- •Individuals with a central venous catheter
- •Individuals requiring the use of antibiotics, immunomodulatory medications, or other probiotics
- •Any participant with a history of chronic gastrointestinal disease
- •Any individual with a chronic uncontrolled medical illness
- •Any female of reproductive age who is currently pregnant, breastfeeding, or sexually active and unwilling or unable to use an acceptable method of contraception.
- •Any participant is unable to appropriately take and store medication
- •Any individual enrolled in a clinical trial evaluating another investigational agent in the last 30 days.
研究组 & 干预措施
Probiotic
Participants will take the E. coli Nissle 1917 as an orally administered medication first while in clinic to be observed for 30 minutes for any hypersensitivity reaction. The dose of Nissle 1917 will be 100mg capsule (2.5-25x109 organism) once daily for a total of 4 days. Participants will then increase the dose to 2 capsules (200mg) once daily for the remaining 26 days of the study period.
干预措施: E. coli Nissle 1917 (Drug)
结局指标
主要结局
Number of adverse events associated with ingestion of E. coli Nissle 1917
时间窗: 30 days
次要结局
未报告次要终点
研究者
Elizabeth Lucas
Principal Invesgator
Nationwide Children's Hospital