A Prospective, Randomized, Double-blinded, Placebo-controlled Parallel Group-Clinical trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis 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
- •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
Probiotics interact with gut-associated lymphoid tissue (GALT) to stimulate immune cells and cytokine production. They improve gut health, reduce allergic reactions, and enhance the body’s ability to fight infections. Probiotics have shown potential in managing conditions like inflammatory bowel disease (IBD), allergies, and even some autoimmune disorders. The Bacillus family contains many important probiotic species, including bacillus coagulans, bacillus subtilis, and bacillus clausii — all of which show significant success in reducing digestive complaints. Bacillus subtilisin particular has been shown to help reduce symptoms of IBS and other gastrointestinal disorders, restore microbial balance in the gut, and reduce inflammation within the gastrointestinal tract. Historically, Bacillus species have been used for their antimicrobial effects and in the fermentation of foods. More recently, they’ve been used for many types of GI ailments, including irritable bowel syndrome, while healing underlying inflammation and disturbance in the gut microbiota. Soil-based microorganisms can successfully help fight the effects of certain bad bacteria in the GI tract, such as C. difficile infection and H. pylori — especially when used alongside conventional antibiotic theraphy. Their capability in combating these pathogens, along with their ability to colonize the GI tract, helps them to effectively restore the natural microbe in the gastrointestinal tract
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.
- •12.Subjects with medical conditions affecting immune status e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets.
- •13.Any surgical treatment within the previous three months or planned during the study.
结局指标
主要结局
•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
•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
•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
- •Incidence of adverse events (AEs) and serious adverse events (SAEs) throughout the study duration, compared between the intervention and placebo groups.(•Changes in vital signs, laboratory parameters, and physical examination findings from baseline to the end of the study, analysed for differences between groups.)
研究者
Dr Vinay BN
Advanced Gastro Care