A Prospective, Randomized, Double-blinded, Placebo-controlled Parallel Group-Clinical trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Coagulans based product in Healthy Adults.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1. Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups.
研究概览
简要总结
Human beings consume a significant number of pathogens every day, primarily bacteria. For several decades, probiotic microorganisms have been utilized in several diets due to their positive effects on human health. The Agriculture Organization of the United States and the World Health Organization defined probiotics in 2001 as bacteria that, when given to a host at adequate levels, improve their health. Regarding probiotics, Lactobacillus and Bifidobacterium are the two most frequently used genera. These bacteria are generally thought of as harmless due to their ability to survive in the body to cure and prevent diseases, unlike the usual pathogens. Along with that, these microorganisms have played a vital role in the process of fermenting milk and food preservation for many years. B. coagulans is a Gram-positive, spore-forming, and motile bacterium. The optimum growth temperature ranges from 35 to 50 °C. The optimum growth pH is 5.5-6.5. The bacteria are facultative anaerobic, and ferment maltose, mannitol, raffinose, sucrose and trehalose with production of acid but not gas. Due to the large amount of lactic acid produced in metabolism, B. coagulans is frequently reported to cause spoilage of dairy products, vegetables or fruits. The spores of B. coagulans can resist gastric acid to reach the small intestine, where they can germinate and propagate. The average time from oral administration to germination is 4-6 h. Approximately 85% of the spores reach the intestine. After a single oral administration, B. coagulans is excreted in faeces for about 7 days. Therefore, in order to achieve long-term treatment, the spores of B. coagulans must be orally ingested daily.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female, aged between 18 and 50 years.
- •2.Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- •3.In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
- •4.Willing to provide fecal samples as per the study requirements.
- •5.Willing to participate voluntarily and provide written informed consent.
排除标准
- •1.Women who are pregnant or lactating.
- •2.Subjects who are taking Antibiotic treatment.
- •3.Subjects suffering from Gastrointestinal disease.
- •4.Subjects suffering from Diabetes.
- •5.Subjects suffering from Chronic/iatrogenic Immunodeficiency.
- •6.Subjects suffering from Abnormal blood pressure.
- •7.Subjects who are allergic to ingredients of the study Product.
- •8.Subjects who are Smoker or alcoholic.
- •9.Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
- •10.Women who are pregnant, breastfeeding, or planning to become pregnant.
- •11.Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
结局指标
主要结局
1. Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups.
时间窗: Day 0 Day 30 Day 60
2. Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups.
时间窗: Day 0 Day 30 Day 60
3. Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups.
时间窗: Day 0 Day 30 Day 60
次要结局
- 1. Incidence of adverse events AEs & serious adverse events SAEs throughout the study duration, compared between the intervention & placebo groups.(2. Changes in vital signs, laboratory parameters, & physical examination findings from baseline to the end of the study, analyzed for differences between groups.)
研究者
Dr Vinay BN
Advanced Gastro Care