To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Safety measured by blood chemistry parameters
研究概览
简要总结
Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.
Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Age 18-65 years at visit 1
- •BMI 19-29
- •Hb ≥ 120 g/l for women and ≥ 130 g/l for men
- •Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
- •Signed informed consent and biobank consent
排除标准
- •Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- •Use of oral antibiotics or probiotics during 2 weeks prior to visit
- •Other probiotics other than the study products are not allowed during the study period.
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.
结局指标
主要结局
Safety measured by blood chemistry parameters
时间窗: 28 days
To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
Tolerability measured by blood chemistry parameters
时间窗: 28 days
To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
次要结局
未报告次要终点