Prospective Tolerability Assessment of a Probiotic Dietary Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Frequency of participants who withdraw from the study due to adverse events during the supplementation period
研究概览
简要总结
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.
详细描述
Background & Significance:
The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects.
Research Design & Methods:
This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-75 years
排除标准
- •Currently taking a probiotic, prebiotic, or fiber supplement (or they were taken within 10 days prior to screening)
- •Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within 28 days prior to screening)
- •Currently taking any supplements or medications impacting gastrointestinal motility
- •Active gastrointestinal infection
- •Current or previous history of chronic bowel disease
- •Current or previous history of liver disease
- •Current or previous history of chronic kidney disease
- •History of gastrointestinal surgery
- •A major medical or surgical event requiring hospitalization within 3 months prior to screening
- •Current or previous history of cardiovascular disease
- •Current or previous history of pre-Diabetes, diabetes mellitus, or hypoglycemia
- •Known infection with human immunodeficiency virus, tuberculosis, hepatitis B or hepatitis C
- •Genitourinary bacterial infections within 28 days prior to screening
- •Current or previous history of seizure disorder
- •Current or previous history of psychiatric illness
- •History of alcoholism
- •Cancer within the last 5 years
- •Smoking or use of nicotine containing products within 28 days prior to screening
- •Use of drugs of abuse and recreational drugs/substances within 12 months prior to screening
- •Known intolerance or allergy to ingredients in the study supplement
- •Women who are lactating, pregnant or planning pregnancy within the next two months
- •Currently participating in another interventional research study or participated in another interventional study within 28 days prior to screening
结局指标
主要结局
Frequency of participants who withdraw from the study due to adverse events during the supplementation period
时间窗: 0-10 days
Tolerability of oral intake of the probiotic supplement will primarily be evaluated by determining the frequency of participants who withdraw from the study due to adverse events during the supplementation period
次要结局
- White blood cell count(0-10 days)
- Mean corpuscular volume(0-10 days)
- Monocytes(0-10 days)
- Aspartate Aminotransferase(0-10 days)
- BUN/Creatinine ratio(0-10 days)
- Calcium(0-10 days)
- Estimated Glomerular Filtration Rate(0-10 days)
- Hemoglobin(0-10 days)
- Mean corpuscular hemoglobin conc.(0-10 days)
- Red cell distribution width(0-10 days)
- Absolute Lymphocytes(0-10 days)
- Globulin(0-10 days)
- Alanine Transaminase(0-10 days)
- Blood urea nitrogen (BUN)(0-10 days)
- Carbon Dioxide(0-10 days)
- Chloride(0-10 days)
- Alkaline Phosphatase(0-10 days)
- Red blood cell count(0-10 days)
- Platelet count(0-10 days)
- Absolute Monocytes(0-10 days)
- Bilirubin(0-10 days)
- Hematocrit(0-10 days)
- Mean corpuscular hemoglobin(0-10 days)
- Mean platelet volume(0-10 days)
- Absolute Eosinophils(0-10 days)
- Basophils(0-10 days)
- Creatinine(0-10 days)
- Absolute Neutrophils(0-10 days)
- Absolute Basophils(0-10 days)
- Neutrophils(0-10 days)
- Lymphocytes(0-10 days)
- Eosinophils(0-10 days)
- Albumin(0-10 days)
- Albumin/Globulin Ratio(0-10 days)
- Sodium(0-10 days)
- Potassium(0-10 days)
- Total Protein(0-10 days)