A Double-Blind, Randomized, Two-Arm, Placebo-Controlled, Comparative Clinical Study to Evaluate the Safety and Efficacy of Bacillus coagulans BCP92 in Healthy Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1. Change in gut microbiome by metagenomic analysis.
研究概览
简要总结
This is a double blinded, randomized, two-arm, placebo controlled, comparative clinical study to evaluate the safety and efficacy of probiotic product in healthy adult subjects.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo laboratory evaluation (blood, urine and stool tests) and evaluation using different scales/questionnaires. Safety will be assessed throughout the study by monitoring vital signs and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having good general health as determined by the Investigator on the basis of medical history, physical examination and vital signs.
- •Females of Childbearing potential must have a negative urine pregnancy test performed during screening.
- •Subjects who agree to refrain from using any probiotic food or supplement, including yogurt/buttermilk during the course of this study.
- •Subjects who agree to refrain from consuming pharmaceuticals such as anti-inflammatory, immunosuppressive, and laxative agents.
- •Subjects willing to maintain a consistent diet and lifestyle routine throughout the study.
- •Subject willing to provide blood and stool samples during the study duration.
排除标准
- •Subjects having history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.
- •Subjects with any pathological problem associated with gastroesophageal reflux disease including Barretts esophagus and malignancy.
- •Subjects with any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject or impact the validity of the study results or interfere with the completion of study according to the protocol.
- •Subjects who are regularly using any medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
- •Subjects consuming probiotics or prebiotics 30 days prior to study.
- •Subjects with known allergy or hypersensitivity to probiotics and/or any ingredients of the test product.
结局指标
主要结局
1. Change in gut microbiome by metagenomic analysis.
时间窗: 1. Day 00 (before product administration), Day 42 | 2. Day 00 (before product administration), Day 21, Day 42
2. Change in Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ).
时间窗: 1. Day 00 (before product administration), Day 42 | 2. Day 00 (before product administration), Day 21, Day 42
次要结局
- Change in eating behavior using Three-Factor Eating Questionnaire-R18 (TFEQ-R18)(Day 00 (before product administration), Day 21, Day 42)
- Change in Daily energy levels using Visual Analogue Scale (VAS)(Day 00 (before product administration), Day 21, Day 42)
- Change in Liver Function tests, Renal Function Tests, Random Blood glucose, Thyroid Function Test, CBC and Urine Test.(Day 00 (before product administration), Day 42)
- Exploratory Endpoints:(Change in Short-Chain Fatty Acids (SCFAs) using Gas Chromatography Mass Spectrometry)
- Safety Endpoints:(Change in Vital Signs and incidence of undesirable /adverse event.)
研究者
Dr Vipul Doshi
Cliantha Research