NCT02176889已完成1 期
A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety and Tolerability: Lab parameters
研究概览
简要总结
The purpose of this study is to determine whether Lactospore is safe in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years of age
- •If female, subject is not of child bearing potential or female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- •Healthy as determined by laboratory results and medical history
- •Normal BMI 18.5 - 29.9 kg/m2
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Subject has any clinically significant medical conditions
- •Subject requires the use of prescribed medications (other than birth control)
- •Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
- •Participation in a clinical research trial within 30 days prior to randomization
- •Clinically significant abnormal laboratory results at screening
- •Allergy or sensitivity to test product ingredients
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
结局指标
主要结局
Safety and Tolerability: Lab parameters
时间窗: Over 30 days
CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels
Safety and Tolerability: Anthropometric safety measures
时间窗: Over 30 days
Blood pressure, Heart Rate, Weight, BMI
Safety and Tolerability: Number of Adverse Events
时间窗: Over 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 YearsHealthyNCT00599443Solvay Pharmaceuticals120
已完成
2 期
2 Regimens of Lactulose for Colonoscopy Preparation in AdultsColonoscopy PreparationNCT01887470Cumberland Pharmaceuticals55
Unknown
不适用
Lactobacillus Helveticus in the Treatment of Major DepressionDepressionNCT04333277Federal University of Minas Gerais40
已完成
不适用
Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract InfectionsImmune HealthNCT04713735Mead Johnson Nutrition76
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk AllergyMilk HypersensitivityNCT00465569Johns Hopkins University20